TE: This policy is used to determine coverage of bariatric surgery for members whose plan documents indclude this benefit. Please review the individual plan document to determine if coverage is available.

Description:
Bariatric surgery is a treatment for morbid obesity in patients who fail to lose weight with conservative measures. There are numerous gastric and intestinal surgical techniques available. While these techniques have heterogeneous mechanisms of action, the result is a smaller gastric pouch that leads to restricted eating. However, these surgeries may lead to malabsorption of nutrients or eventually to metabolic changes.

Adults With Morbid Obesity
For individuals who are adults with morbid obesity who receive gastric bypass, the evidence includes randomized controlled trials (RCTs), observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. TEC Assessments and other systematic reviews of RCTs and observational studies found that gastric bypass improves health outcomes, including weight loss and remission of Type 2 diabetes. A TEC Assessment found similar weight loss with open and laparoscopic gastric bypass. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive laparoscopic adjustable gastric banding (LAGB), the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that LAGB is a reasonable alternative to gastric bypass. There is less weight loss with LAGB than with gastric bypass, but LAGB is less invasive and is associated with fewer serious adverse events. 

For individuals who are adults with morbid obesity who receive sleeve gastrectomy (SG), the evidence includes RCTs, observational studies (evaluating SG alone and comparing SG with gastric bypass), as well as systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that SG results in substantial weight loss and that this weight loss is durable for at least 5 years. A meta-analysis found that short-term weight loss was similar after SG compared with gastric bypass. Long-term weight loss was greater after gastric bypass, but SG is associated with fewer adverse events. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive biliopancreatic diversion (BPD) with duodenal switch, the evidence includes nonrandomized comparative studies, observational studies, and a systematic review. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Nonrandomized comparative studies have found significantly higher weight loss after BPD with duodenal switch compared with gastric bypass at 1 year. A large case series found sustained weight loss after 7 years. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive BPD without duodenal switch, the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A TEC Assessment reviewed the available observational studies and concluded that weight loss was similar after BPD without a duodenal switch or gastric bypass. However, concerns have been raised about complications associated with BPD without duodenal switch, especially long-term nutritional and vitamin deficiencies. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive vertical-banded gastroplasty, the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A TEC Assessment identified 8 nonrandomized comparative studies evaluating vertical-banded gastroplasty, and these studies found that weight loss was significantly greater with open gastric bypass. Moreover, vertical-banded gastroplasty has relatively high rates of complications, revisions, and reoperations. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive 2-stage bariatric surgery procedures, the evidence includes a small RCT and observational studies. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is a lack of evidence that 2-stage bariatric procedures improve outcomes compared with 1-stage procedures. The small RCT compared intragastric balloon (IGB) plus gastric bypass with the standard of care plus gastric bypass and did not detect a difference in weight loss at 6 months postsurgery. Case series have shown relatively high complication rates in 2-stage procedures, and patients are at risk of complications in both stages. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive laparoscopic gastric plication, the evidence includes 2 RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A 2014 systematic review only identified a small nonrandomized comparative study comparing laparoscopic gastric plication with other bariatric surgery procedures. Since the systematic review, 2 RCTs have been published, one comparing laparoscopic gastric plication with a sham procedure and another comparing laparoscopic gastric plication with SG. Laparoscopic gastric plication was more effective than sham at 1-year follow-up and equally effective as SG at 2-year follow-up. Additional comparative studies and RCTs with longer follow-up are needed to permit conclusions about the safety and efficacy of laparoscopic gastric plication. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive single anastomosis duodenoileal bypass with SG (SADI-S), the evidence includes observational studies. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. No controlled trials have evaluated SADI-S. There are a few case series, the largest of which had fewer than 100 patients. A retrospective chart review of patients receiving gastric bypass, BPD, and SADI-S, reported that among patients without diabetes, SADI-S was more effective in weight loss and cholesterol outcomes than gastric bypass. Among patients with diabetes, SADI-S and BDP had higher remission rates than gastric bypass. Comparative studies and especially RCTs are needed to permit conclusions about the safety and efficacy of SADI-S. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive duodenojejunal sleeve, the evidence includes RCTs and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A systematic review of duodenojejunal sleeves included 5 RCTs and found significantly greater short-term weight loss (12 – 24 weeks) with the sleeves compared with medical therapy. There was no significant difference in symptoms associated with diabetes. All RCTs were small and judged by systematic reviewers to be at high-risk of bias. High-quality comparative studies are needed to permit conclusions on the safety and efficacy of the procedure. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive IGB devices, the evidence includes RCTs, systematic reviews, and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. RCTs assessing the 2 IGB devices approved by the Food and Drug Administration have found significantly greater weight loss with IGB than with sham treatment or lifestyle therapy alone after 6 months (maximum length of device use). Some adverse events were reported, mainly related to accommodation of the balloon in the stomach; in a minority of cases, these adverse events were severe. One RCT followed patients for an additional 6 months after IGB removal and found sustained weight loss. There are limited data on the durability of weight loss in the long-term. Comparative data are lacking. A large case series found that patients gradually regained weight over time. Moreover, it is unclear how 6 months of IGB use would fit into a long-term weight loss and maintenance intervention. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive an aspiration therapy device, the evidence includes an RCT and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. The RCT found significantly greater weight loss with aspiration therapy than lifestyle therapy at 1 year. One small case series reported on 15 patients at 2 years. The total amount of data on aspiration therapy remains limited and additional studies are needed before conclusions can be drawn about the effects of treatment on weight loss, metabolism and nutrition and long-term durability of treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

Revision Bariatric Surgery
For individuals who are adults with morbid obesity and failed bariatric surgery who receive revision bariatric surgery, the evidence includes case series and registry data. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Case series have shown that patients receiving revision bariatric surgery experienced satisfactory weight loss. Data from a multinational bariatric surgery database has found that corrective procedures following primary bariatric surgery are relatively uncommon but generally safe and efficacious. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Adults With Type 2 Diabetes
For individuals who are diabetic and not morbidly obese who receive gastric bypass, SG, BPD or LAGB, the evidence includes RCTs, nonrandomized comparative studies, and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that certain types of bariatric surgery are more efficacious than medical therapy as a treatment for Type 2 diabetes in obese patients, including those with a body mass index (BMI) between 30 and 34.9 kg/m². The greatest amount of evidence is on gastric bypass. Systematic reviews have found significantly greater remission rates of diabetes, decrease in hemoglobin A1c levels, and decrease in BMI with bariatric surgery than with nonsurgical treatment. The efficacy of surgery is balanced against the short-term risks of the surgical procedure. Most RCTs in this population have 1 to 3 years of follow-up; 1 RCT that included patients with BMI between 30 and 34.9 kg/m² had 5-year follow-up data. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

There are clinical concerns about durability and long-term outcomes at 5 to 10 years as well as potential variation in observed outcomes in community practice vs. clinical trials. As a result, bariatric surgery for individuals who are diabetic and not morbidly obese is considered not medically necessary.

Nondiabetic and Nonobese Adults
For individuals who are not diabetic and not morbidly obese who receive any bariatric surgery procedure, the evidence includes RCTs, nonrandomized comparative studies, and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is limited evidence for bariatric surgery in patients who are not diabetic or morbidly obese. A few small RCTs and case series have reported a loss of weight and improvements in comorbidities for this population. However, the evidence does not permit conclusions on the long-term risk-benefit ratio of bariatric surgery in this population. The evidence is insufficient to determine the effects of the technology on health outcomes.

Adolescent Children With Morbid Obesity
Gastric Bypass, LAGB or SG
For individuals who are adolescent children with morbid obesity who receive gastric bypass or LAGB or SG, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of studies on bariatric surgery in adolescents, who mainly received gastric bypass or LAGB or SG, found significant weight loss and reductions in comorbidity outcomes with bariatric surgery. For bariatric surgery in the adolescent population, although data are limited on some procedures, studies have generally reported that weight loss and reduction in risk factors for adolescents are similar to that for adults. Most experts and clinical practice guidelines have recommended that bariatric surgery in adolescents be reserved for individuals with severe comorbidities, or for individuals with a BMI greater than 50 kg/m². Also, greater consideration should be placed on the patient developmental stage, on the psychosocial aspects of obesity and surgery, and on ensuring that the patient can provide fully informed consent. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Bariatric Surgery Other Than Gastric Bypass, LAGB or SG
For individuals who are adolescent children with morbid obesity who receive bariatric surgery other than gastric bypass or LAGB or SG, the evidence includes systematic reviews and a cohort study. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Studies using bariatric surgery other than gastric bypass, LAGB or SG, have small sample sizes. Results from a meta-analysis including patients using other procedures have shown significant improvements in BMI reduction, fasting blood insulin, and total cholesterol, although the estimates have wide confidence intervals, limiting interpretation. The evidence is insufficient to determine the effects of the technology on health outcomes.

Preadolescent Children With Morbid Obesity
For individuals who are preadolescent children with morbid obesity who receive bariatric surgery, the evidence includes no studies focused on this population. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Several studies of bariatric surgery in adolescents have also included children younger than 12 years old, but findings were not reported separately for preadolescent children. Moreover, clinical practice guidelines have recommended against bariatric surgery for preadolescent children. The evidence is insufficient to determine the effects of the technology on health outcomes.

Hiatal Hernia Repair With Bariatric Surgery
For individuals with morbid obesity and a preoperative diagnosis of a hiatal hernia who receive hiatal hernia repair with bariatric surgery, the evidence includes cohort studies and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Results from the cohort studies and case series have shown that, when a preoperative diagnosis of a hiatal hernia has been present, repairing the hiatal hernia during bariatric surgery resulted in fewer complications. However, the results are limited to individuals with a preoperative diagnosis. There was no evidence on the use of hiatal hernia repair when the hiatal hernia diagnosis is incidental. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

BACKGROUND 
BARIATRIC SURGERY
Bariatric surgery is performed to treat morbid (clinically severe) obesity. Morbid obesity is defined as a body mass index (BMI) greater than 40 kg/m² or a BMI greater than 35 kg/m² with associated complications including, but not limited to, diabetes, hypertension, or obstructive sleep apnea. Morbid obesity results in a very high risk for weight-related complications, such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (for men: colon, rectal, prostate; for women: breast, uterine, ovarian), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 fewer years than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy. 

The first treatment of morbid obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few morbidly obese individuals can reduce and control weight through diet and exercise. Most patients find it difficult to comply with these lifestyle modifications on a long-term basis.

When conservative measures fail, some patients may consider surgical approaches. A 1991 National Institutes of Health Consensus Conference defined surgical candidates as “those patients with a BMI of greater than 40 kg/m², or greater than 35 kg/m² in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes.”¹ 

Resolution (cure) or improvement of Type 2 diabetes (T2D) after bariatric surgery and observations that glycemic control may improve immediately after surgery, before a significant amount of weight is lost, have promoted interest in a surgical approach to treatment of T2D. The various surgical procedures have different effects, and gastrointestinal rearrangement seems to confer additional antidiabetic benefits independent of weight loss and caloric restriction. The precise mechanisms are not clear, and multiple mechanisms may be involved. Gastrointestinal peptides, e.g., glucagon-like peptide-1 (1GLP-1), glucose-dependent insulinotropic peptide (GIP), and peptide YY (PYY), are secreted in response to contact with unabsorbed nutrients and by vagally mediated parasympathetic neural mechanisms. GLP-1 is secreted by the L cells of the distal ileum in response to ingested nutrients and acts on pancreatic islets to augment glucose-dependent insulin secretion. It also slows gastric emptying, which delays digestion, blunts postprandial glycemia, and acts on the central nervous system to induce satiety and decrease food intake. Other effects may improve insulin sensitivity. GIP acts on pancreatic beta cells to increase insulin secretion through the same mechanisms as GLP-1, although it is less potent. PYY is also secreted by the L cells of the distal intestine and increases satiety and delays gastric emptying.

Types of Bariatric Surgery Procedures
The following summarizes the most common types of bariatric surgery procedures.

Open Gastric Bypass
The original gastric bypass surgeries were based on the observation that post-gastrectomy patients tended to lose weight. The current procedure (CPT code 43846) involves both a restrictive and a malabsorptive component, with horizontal or vertical partition of the stomach performed in association with a Roux-en-Y procedure (i.e., a gastrojejunal anastomosis). Thus, the flow of food bypasses the duodenum and proximal small bowel. The procedure may also be associated with an unpleasant “dumping syndrome,” in which a large osmotic load delivered directly to the jejunum from the stomach produces abdominal pain and/or vomiting. The dumping syndrome may further reduce intake, particularly in “sweets eaters.” Surgical complications include leakage and operative margin ulceration at the anastomotic site. Because the normal flow of food is disrupted, there are more metabolic complications than with other gastric restrictive procedures, including iron deficiency anemia, vitamin B12 deficiency, and hypocalcemia, all of which can be corrected by oral supplementation. Another concern is the ability to evaluate the “blind” bypassed portion of the stomach. Gastric bypass may be performed with either an open or laparoscopic technique. 

Note: In 2005, the CPT code 43846 was revised to indicate that the short limb must be 150 cm or less, compared with the previous 100 cm. This change reflects the common practice in which the alimentary (i.e., jejunal limb) of a gastric bypass has been lengthened to 150 cm. This length also serves to distinguish a standard gastric bypass with a very long, or very, very long gastric bypass, as discussed further here.

Laparoscopic Gastric Bypass
CPT code 43644 was introduced in 2005 and described the same procedure as open gastric bypass (CPT code 43846), but performed laparoscopically.

Adjustable Gastric Banding
Adjustable gastric banding (CPT code 43770) involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir implanted subcutaneously in the rectus sheath. Injecting the reservoir with saline will alter the diameter of the gastric band; therefore, the rate-limiting stoma in the stomach can be progressively narrowed to induce greater weight loss, or expanded if complications develop. Because the stomach is not entered, the surgery and any revisions, if necessary, are relatively simple.

Complications include slippage of the external band or band erosion through the gastric wall. Adjustable gastric banding has been widely used in Europe. Two banding devices are approved by the Food and Drug Administration (FDA) for marketing in the United States. The first to receive FDA approval was the LAP-BAND (original applicant, Allergan, BioEnterics, Carpinteria, CA; now Apollo Endosurgery, Austin, TX). The labeled indications for this device are as follows:

"The LAP-BAND^® system is indicated for use in weight reduction for severely obese patients with a body mass index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lb or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives."

In 2011, FDA-labelled indications for the LAP-BAND were expanded to include patients with a BMI from 30 to 34 kg/m² with at least 1 obesity-related comorbid condition.

The second adjustable gastric banding device approved by FDA through the premarket approval process is the REALIZE^® model (Ethicon Endo-Surgery, Cincinnati, Ohio). Labeled indications for this device are:

“The [REALIZE] device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index of at least 40 kg/m², or a BMI of at least 35 kg/m² with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.”

Sleeve Gastrectomy
A sleeve gastrectomy (CPT code 43775) is an alternative approach to gastrectomy that can be performed on its own or in combination with malabsorptive procedures (most commonly biliopancreatic diversion [BPD] with duodenal switch). In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or sleeve. The pyloric sphincter is preserved, resulting in a more physiologic transit of food from the stomach to the duodenum and avoiding the dumping syndrome (overly rapid transport of food through stomach into intestines) seen with distal gastrectomy. This procedure is relatively simple to perform and can be done as an open or laparoscopic procedure. Some surgeons have proposed the sleeve gastrectomy as the first in a 2-stage procedure for very high-risk patients. Weight loss following sleeve gastrectomy may improve a patient’s overall medical status and, thus, reduce the risk of a subsequent more extensive malabsorptive procedure (e.g., BPD).

Biliopancreatic Bypass Diversion
The BPD procedure (also known as the Scopinaro procedure; CPT code 43847) developed and used extensively in Italy, was designed to address drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPD consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The procedure consists of the following components:

1. A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.
2. A 200-cm long “alimentary tract” consists of 200 cm of ileum connecting the stomach to a common distal segment. 
3. A 300- to 400-cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.
4. A 50- to 100-cm “common tract” is where food from the alimentary tract mixes with biliopancreatic juices from the biliary tract. Food digestion and absorption, particularly of fats and starches, are therefore limited to this small segment of bowel, i.e., creating a selective malabsorption. The length of the common segment will influence the degree of malabsorption. 
5. Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy. 

Many potential metabolic complications are related to BPD, including, most prominently, iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. In addition, several case reports have noted liver failure resulting in death or liver transplant. 

BPD With Duodenal Switch
CPT code 43845, which specifically identifies the duodenal switch procedure, was introduced in 2005. The duodenal switch procedure is a variant of the BPD previously described. In this procedure, instead of performing a distal gastrectomy, a sleeve gastrectomy is performed along the vertical axis of the stomach. This approach preserves the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum, similar to the BPD, to create the alimentary limb. Preservation of the pyloric sphincter is intended to ameliorate the dumping syndrome and decrease the incidence of ulcers at the duodenoileal anastomosis by providing a more physiologic transfer of stomach contents to the duodenum. The sleeve gastrectomy also decreases the volume of the stomach and decreases the parietal cell mass. However, the basic principle of the procedure is similar to that of the BPD, i.e., producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.

Vertical-Banded Gastroplasty
Vertical-banded gastroplasty (VBG; CPT code 43842) was formerly one of the most common gastric restrictive procedures performed in the United States, but has now been replaced by other restrictive procedures due to high rates of revisions and reoperations. In this procedure, the stomach is segmented along its vertical axis. To create a durable reinforced and rate-limiting stoma at the distal end of the pouch, a plug of stomach is removed, and a propylene collar is placed through this hole and then stapled to itself. Because the normal flow of food is preserved, metabolic complications are uncommon. Complications include esophageal reflux, dilation, or obstruction of the stoma, with the latter 2 requiring reoperation. Dilation of the stoma is a common reason for weight regain. VBG may be performed using an open or laparoscopic approach.

Long-Limb Gastric Bypass (i.e., > 150 cm)
Variations of gastric bypass procedures have been described, consisting primarily of long-limb Roux-en-Y procedures (CPT code 43847), which vary in the length of the alimentary and common limbs. For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump, creating the alimentary limb. The remaining pancreaticobiliary limb, consisting of stomach remnant, duodenum, and length of proximal jejunum, is then anastomosed to the ileum, creating a common limb of variable length in which the ingested food mixes with the pancreaticobiliary juices. While the long alimentary limb permits absorption of most nutrients, the short common limb primarily limits absorption of fats. The stomach may be bypassed in a variety of ways (e.g., resection or stapling along the horizontal or vertical axis). Unlike the traditional gastric bypass, which is a gastric restrictive procedure, these very long-limb Roux-en-Y gastric bypasses combine gastric restriction with some element of malabsorptive procedure, depending on the location of the anastomoses. Note that CPT code for gastric bypass (43846) explicitly describes a short limb ( < 150 cm) Roux-en-Y gastroenterostomy, and thus would not apply to long-limb gastric bypass.

Laparoscopic Malabsorptive Procedure
CPT code 43645 was introduced in 2005 to specifically describe a laparoscopic malabsorptive procedure. However, the code does not specifically describe any specific malabsorptive procedure.

Weight Loss Outcomes
There is no uniform standard for reporting results of weight loss or for describing a successful procedure. Common methods of reporting the amount of body weight loss are percent of ideal body weight achieved or percent of excess body weight (EBW) loss, with the latter most commonly reported. These 2 methods are generally preferred over the absolute amount of weight loss, because they reflect the ultimate goal of surgery: to reduce weight into a range that minimizes obesity-related morbidity. Obviously, an increasing degree of obesity will require a greater amount of weight loss to achieve these target goals. There are different definitions of successful outcomes, but a successful procedure is often considered one in which at least 50% of EBW is lost, or when the patient returns to within 30% of ideal body weight. The results may also be expressed as the percentage of patients losing at least 50% of EBW. Table 1 summarizes the variations in reporting weight loss outcomes. 

Table 1. Weight Loss Outcomes

Outcome Measure	Definition	Clinical Significance
Decrease in weight	Absolute difference in weight pre- and post-treatment	Unclear relation to outcomes, especially in morbidly obese
Decrease in BMI	Absolute difference in BMI pre- and post-treatment	May be clinically significant if change in BMI clearly leads to change in risk category
Percent EBW loss	Amount of weight loss divided by EBW	Has anchor to help frame clinical significance; unclear threshold for clinical significance
Percent patients losing > 50% of EBW	No. of patients losing > 50% EBW divided by total patients	Additional advantage of framing on per patient basis. Threshold for significance (> 50%) arbitrary.
Percent ideal body weight	Final weight divided by ideal body weight	Has anchor to help frame clinical significance; unclear threshold for clinical significance

BMI: body mass index; EBW: excess body weight.

Durability of Weight Loss
Weight change (i.e., gain or loss) at yearly intervals is often reported. Weight loss at 1 year is considered the minimum length of time for evaluating these procedures; weight loss at 3 to 5 years is considered an intermediate time period for evaluating weight loss; and weight loss at 5 to 10 years or more is considered to represent long-term weight loss following bariatric surgery.

Short-Term Complications (Operative and Perioperative Complications < 30 Days)
In general, the incidence of operative and perioperative complications is increased in obese patients, particularly in thromboembolism and wound healing. Other perioperative complications include anastomotic leaks, bleeding, bowel obstruction, and cardiopulmonary complications (e.g., pneumonia, myocardial infarction).

Reoperation Rate
Reoperation may be required to either “take down” or revise the original procedure. Reoperation may be particularly common in VBG due to pouch dilation. 

Long-Term Complications (Metabolic Adverse Events, Nutritional Deficiencies)
Metabolic adverse events are of particular concern in malabsorptive procedures. Other long-term complications include anastomotic ulcers, esophagitis, and procedure-specific complications such as band erosion or migration for gastric-banding surgeries.

Improved Health Outcomes in Terms of Weight-Related Comorbidities
Aside from psychosocial concerns, which may be considerable, 1 motivation for bariatric surgery is to decrease the incidence of complications of obesity, such as diabetes, cardiovascular risk factors (i.e., increased cholesterol, hypertension), obstructive sleep apnea, or arthritis. Unfortunately, these final health outcomes are not consistently reported. 

REGULATORY STATUS
Forms of bariatric surgery performed without specific implantable devices are surgical procedures and, as such, are not subject to regulation by the FDA.

Table 2 shows forms of bariatric surgery with implantable devices approved by FDA through the premarket approval process.

Table 2: FDA-Approved Bariatric Surgery Devices

Device	Manufacturer	PMA Date	Labeled Indications
AspireAssist System	Aspire Bariatrics	Jun 2016	For long-term use in conjunction with lifestyle therapy and continuous medical monitoring in obese adults > 22 y, with a BMI of 35.0 to 55.0 kg/m2 and no contraindications to the procedure who have failed to achieve and maintain weight loss with nonsurgical weight loss therapy
ORBERA® intragastric balloon system	Apollo Endosurgery	Aug 2015	For use in obese adults (BMI, 30 – 40 kg/m2 ) who have failed weight reduction with diet and exercise, and have no contraindications. Maximum placement time is 6 mo. Balloon placed endoscopically and inflated with saline.
ReShape® Integrated Dual Balloon System	ReShape Medical	Jul 2015	For use in obese adults (BMI, 30 – 40 kg/m2) and ≥ 1 comorbid conditions who have failed weight reduction with diet and exercise, and have no contraindications. Maximum placement time is 6 mo. Balloon delivered transorally and inflated with saline.
LAP-BAND® Adjustable Gastric Banding System	Apollo Endosurgery (original applicant: Allergan)	Apr 2010	For use in weight reduction for severely obese adults with BMI of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with ≥ 1 severe comorbid conditions who have failed more conservative weight-reduction alternatives (e.g., supervised diet, exercise, behavior modification programs).
REALIZE® Adjustable Gastric Band	Ethicon Endosurgery	Nov 2007	For use in weight reduction for morbidly obese patients and for individuals with BMI of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with ≥ 1 comorbid conditions, or those who are ≥ 45.4 kg over their estimated ideal weight. Indicated for use only in morbidly obese adults who have failed more conservative weight-reduction alternatives (e.g., supervised diet, exercise, behavior modification programs).

BMI: body mass index: FDA: Food and Drug Administration; PMA: premarket approval. 

In February 2017, the FDA issued a letter to health care providers discussing the potential risks with liquid-filled intragastric balloons in response to reports of 2 types of adverse events related to the balloons. Several dozen reports concerned spontaneous overinflation of the balloons, which caused pain, swelling, and vomiting. The second set of adverse event reports indicated that acute pancreatitis developed in several patients due to compression of gastrointestinal structures. These reports involved both ReShape and ORBERA brands. The adverse events may require premature removal of the balloons.

In August 2017, the FDA issued a second letter to health care providers informing them of 5 unanticipated deaths occurring from 2016 through the time of the letter, due to intragastric balloons. The FDA recommended close monitoring of patients receiving these devices.

Related Policies
70173 Gastric Electrical Stimulation

Policy:
BARIATRIC SURGERY IN ADULTS WITH MORBID OBESITY
The following bariatric surgery procedures may be considered MEDICALLY NECESSARY for the treatment of morbid obesity  in adults who have successfully completed a comprehensive nonsurgical weight management program that includes but is not limited to nutrition counseling, counseling for increase in activity, cognitive behavior therapy and possible medication support (see Policy Guidelines section for patient selection criteria). Bariatric surgery should be performed in appropriately selected patients, by surgeons who are adequately trained and experienced in the specific techniques used, and in institutions that support a comprehensive bariatric surgery program, including long-term monitoring and follow-up post-surgery and that are accredited by Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (https://www.facs.org/quality programs/mbsaqip). 

• Gastric bypass using a Roux-en-Y anastomosis, either open or laparoscopic
• Sleeve gastrectomy
• Open or laparoscopic biliopancreatic bypass (i.e., Scopinaro procedure) with duodenal switch based on specific prior authorization review 

NOTE:  BARIATRIC SURGERY PROCEDURES ARE LIMITED TO ONE PER LIFETIME.

The following bariatric surgery procedures are considered investigational/unproven therefore is considered NOT MEDICALLY NECESSARY for the treatment of morbid obesity in adults who have failed weight loss by non-surgical measures: 

• Vertical-banded gastroplasty
• Laparoscopic adjustable gastric banding   
• Gastric bypass using a Billroth II type of anastomosis (mini-gastric bypass) 
• Biliopancreatic bypass without duodenal switch 
• Long-limb gastric bypass procedure (i.e., > 150 cm) 
• Two-stage bariatric surgery procedures (e.g., sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time) 
• Laparoscopic gastric plication 
• Single anastomosis duodeno-ileal bypass with sleeve gastrectomy.

The following endoscopic procedures are investigational/unproven therefore is considered NOT MEDICALLY NECESSARY as a primary bariatric procedure or as a revision procedure (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches):

• Insertion of the StomaphyX™ device
• Endoscopic gastroplasty
• Use of an endoscopically placed duodenojejunal sleeve 
• Intragastric balloons  
• Aspiration therapy device. 

BARIATRIC SURGERY IN PREADOLESCENT CHILDREN
Bariatric surgery is considered investigational/unproven therefore is considered NOT MEDICALLY NECESSARY for the treatment of morbid obesity in preadolescent children. 

BARIATRIC SURGERY IN PATIENTS WITH A BMI LESS THAN 35 KG/M²
Bariatric surgery is considered NOT MEDICALY NECESARY for patients with a BMI less than 35 kg/m². 

REVISION BARIATRIC SURGERY
Revision surgery to address perioperative or late complications of the original bariatric procedure may be considered MEDICALLY NECESSARY. They include, but are not limited to, staple-line failure, obstruction, stricture, non-absorption resulting in hypoglycemia or malnutrition, weight loss of 20% or more below ideal body weight, and band slippage that cannot be corrected with manipulation or adjustment (see Policy Guidelines section). 

Revision of a primary bariatric procedure that has failed due to dilation of the gastric pouch or dilation proximal to an adjustable gastric band (documented by upper gastrointestinal examination or endoscopy) is considered MEDICALLY NECESSARY if the initial procedure was successful in inducing weight loss prior to pouch dilation, and the patient has been compliant with a prescribed nutrition and exercise program.  Converting from one surgical intervention to a second, particularly because the desired weight loss has not been realized, is considered a second procedure and not a revision and is subject to the limitation of one procedure per lifetime.

BARIATRIC SURGERY IN ADOLESCENTS
Bariatric surgery in adolescents may be considered MEDICALLY NECESSARY according to the same weight based criteria used for adults, but greater consideration should be given to psychosocial and informed consent issues (see Policy Guidelines section). In addition, any devices used for bariatric surgery must be used in accordance with the U.S. Food and Drug Administration-approved indications.

CONCOMITANT HIATAL HERNIA REPAIR WITH BARIATRIC SURGERY
Repair of a hiatal hernia at the time of bariatric surgery may be considered MEDICALLY NECESSARY for patients who have a preoperatively diagnosed hiatal hernia with indications for surgical repair (see Policy Guidelines section). 

Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of a preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair, is considered investigational/unproven therefore is considered NOT MEDICALLY NECESSARY.

Policy Guidelines:
Patient Selection Criteria 
Morbid obesity is defined as a body mass index (BMI) 40 kg/m² or more or a BMI 35 kg/m² or more with at least 1 clinically significant obesity-related disease such as diabetes, obstructive sleep apnea, coronary artery disease, or hypertension for which these complications or diseases are not controlled by best practice medical management.

While there is limited evidence on which to assess the long-term impacts of bariatric surgery for patients younger than age 18 years, severely obese (BMI ≥ 40 kg/m² or 140% of the 95th percentile for age and sex, whichever is lower) adolescents with commonly present though not required comorbidities, or who have a BMI of 35 kg/m² or greater (or 120% of the 95th percentile for age and sex, whichever is lower) with clinically significant disease may be considered for bariatric surgery according to the American Academy of Pediatrics.¹ U.S. Food and Drug Administration (FDA) premarket approval for the LAP-BAND^® System indicates it is intended for severely obese adults. (The clinical study submitted to FDA for approval of the LAP-BAND was restricted to adults ages 18 – 55 years.)

Patients should have documented success base on active participation in comprehensive non-surgical measures for weight reduction prior to consideration of bariatric surgery.  A physician supervised 4 – 6 month comprehensive non-surgical weight management program will include but not be limited to nutritional counseling, counseling for a healthy increase in activity, cognitive behavior therapy and possibly medication support. Special consideration may be given to individuals with Type 2 diabetes regarding program duration and documented weight loss.

Coding
Please see the Codes table for details.

Benefit Application
BlueCard/National Account Issues
State mandates and contractual exclusions may apply to coverage eligibility of bariatric surgery in general.

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) (i.e., the Lap-Band device) may not be considered investigational, and thus coverage eligibility of these devices may be assessed only on the basis of their medical necessity.

Rationale
This evidence review was created in July 1996 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through Dec. 16, 2021.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice. The following is a summary of the key literature to date.

Overview: Bariatric Surgery in Adults With Morbid Obesity
There is a vast literature on bariatric surgery for adults with morbid obesity. This literature is characterized by a preponderance of single-arm clinical series from individual institutions. These types of studies can be used to determine the amount of weight loss expected from surgery, the durability of the weight loss, and the rate of adverse events. However, these studies are not adequate for determining the comparative efficacy of bariatric surgery versus conservative treatment, or the comparative efficacy of different bariatric surgery techniques. Some comparative trials, including randomized and nonrandomized designs, compare bariatric surgery with conservative therapy and/or compare outcomes of different bariatric surgery procedures. RCTs of bariatric surgery have been performed but are limited and insufficient to draw conclusions about comparisons of bariatric surgery and conservative treatments for weight loss.¹ RCTs are difficult in bariatric surgery because many experts consider it inappropriate or unethical to randomize patients to bariatric surgery. Also, most patients and clinicians have strong preferences for treatment, which result in a select population that might agree to randomization and, therefore, limited generalizability. As a result, the emphasis for this evidence review is on comparative nonrandomized trials of bariatric surgery and nonsurgical therapy or of different types of bariatric surgery procedures.

Swedish Obese Subjects Trial
The Swedish Obese Subjects (SOS) trial is the most influential study of bariatric surgery versus conservative treatment. The SOS trial started in 1987 with a registry containing a detailed questionnaire and clinical data on obese patients with a body mass index (BMI) greater than 34 kg/m² at 480 primary health care centers in Sweden. From this registry, patients who met eligibility criteria were recruited and offered bariatric surgery. Thus, SOS patients self-selected into treatment, and there were baseline differences between groups, primarily reflecting more excess weight and a higher incidence of comorbidities in the surgery group. A total of 2,010 people chose surgery, and 2,037 people chose conservative care. Each surgical patient was matched on 18 clinical variables with a patient from the registry who received nonsurgical treatment (usual care). Each surgeon chose the surgical procedure offered. Most procedures were vertical-banded gastroplasty (VBG; > 70%), with gastric bypass (6%) and gastric banding (23%) procedures performed as well. Usual care in the SOS trial was the local practice of the primary care center and usually did not include pharmacologic treatment. Patients were followed at regular intervals with repeat questionnaires and physical examinations for at least 10 years.

Many publications from this trial have reported on methods, weight loss, and clinical outcomes.^2,3,4,5 The following general conclusions can be drawn from the SOS study:

• Weight loss was greater with bariatric surgery than with conservative treatment. At 10 years of follow-up, weight loss in the surgery group was 16% of total body weight compared with a weight gain of 1.6% in the conservative treatment group.
• There was significant improvement in glucose control for diabetics and reduced incidence of new cases of diabetes.
• The effect on other cardiovascular risk factors (e.g., hypertension, lipidemia) was also positive, but less marked than that seen for diabetes.
• Mortality was reduced by 29% after a mean follow-up of 10.9 years.
• Quality of life improved in the 2- to 10-year follow-up period, with the degree of improvement in quality of life correlating with the amount of weight loss.

Longitudinal Assessment of Bariatric Surgery Consortium
The Longitudinal Assessment of Bariatric Surgery Consortium study is a large prospective, longitudinal, noncomparative study of patients who underwent Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) with follow-up through 3 years post-procedure.⁶ The study enrolled 2458 subjects, with a median BMI of 45.9 kg/m2 (interquartile range [IQR], 41.7 to 51.5 kg/m²). For their first bariatric surgical procedure, 1,738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At 3-year follow-up, for 1,533 RYGB patients with available data, the percentage of baseline weight lost was 31.5% (IQR, 24.6% to 38.4%). For the 439 LAGB patients with available data at 3 years, the percentage of baseline weight loss was 15.9% (IQR, 7.9% to 23.0%). At 3 years post-surgery, 67.5% and 28.5% of RYGB and LAGB patients, respectively, had at least partial diabetes remission. Dyslipidemia was in remission in 61.9% and 27.1% of RYGB and LAGB patients, respectively. Subsequent bariatric procedures (revision or reversal) were required in 0.3% (95% confidence interval [CI], 0.1% to 0.9%) of the RYGB patients and in 17.5% (95% CI, 13.8% to 21.9%) of LAGB patients

National Patient-Centered Clinical Research Network — Bariatric Study
The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study is a large retrospective, comparative study of 65,093 patients aged 20 to 79 years who underwent RYGB (n = 32,208), LAGB (n = 29,693), or sleeve gastrectomy (SG)(n = 3,192) with follow-up through 5 years post-procedure.⁷ Mean estimated percent total weight loss (% TWL) was calculated at 1, 3 and 5 years in addition to 30-day rates of major adverse events. Study results are summarized in Table 3. This study demonstrates that RYGB is associated with a greater weight loss than SG (p < .001) and that LAGB is associated with the lowest amount of weight loss as observed in a large and diverse patient cohort.

Table 3. National Patient-Centered Clinical Research Network — Bariatric Study Results

	Mean TWL, % (95% CI)			MAE Rate,% (95% CI)
Group (na)	1 Year	3 Years	5 Years	30 Days
RYGB (19,029; 9225; 3676)	-31.2 (-31.3 to -31.1)	-29.0 (-29.2 to -28.8)	-25.5 (-25.9 to -25.1)	5.0 (NR)
LAGB (1681; 943; 337)	-13.7 (-14.0 to -13.3)	-12.7 (-13.5 to -12.0)	-11.7 (-13.1 to -10.2)	2.9 (NR)
SG (14,929; 5304; 1088)	-25.2 (-25.4 to -25.1)	-21.0 (-21.3 to -20.7)	-18.8 (-19.6 to -18.0)	2.6 (NR)

CI: confidence interval; LAGB: laparoscopic adjustable gastric banding; MAE: major adverse event; NR: not reported; RYGB: Roux-en-Y gastric bypass; SG: sleeve gastrectomy; TWL: total weight loss.
^a Number of patients evaluated at 1, 3 and 5 years, respectively. 

Systematic Reviews
Numerous systematic reviews have compared the efficacy of bariatric surgery with conservative therapy or compared different types of bariatric surgery techniques, some of which are older and/or do not extend across the full range of available studies.^8,9,10,11

Cosentino et al. (2021) performed a network meta-analysis of 43 RCTs comparing the efficacy of bariatric surgery versus medical therapy, as well as comparing different types of bariatric surgery techniques.¹² Most included trials were 1 year in duration but a few extended to 5 years. Results demonstrated that surgery reduced BMI more effectively than medical therapy (mean difference [MD], -6.632 kg/m2; 95% CI, -8.29 to -4.97), but increased risk for severe adverse events (odds ratio [OR], 3.06; 95% CI, 1.09 to 8.57). When comparing different procedures to medical therapy, duodenal switch (DS) and bilio-pancreatic diversion (BPD) appeared to be more effective than other procedures, whereas greater curvature plication, LAGB, and laparoscopic vertical banded gastroplasty produced a smaller weight loss than other interventions. When comparing different types of bariatric surgery techniques on BMI change, RYGB was superior to LAGB (MD, -4.26; 95% CI, -6.02 to -2.50; n = 2 studies) and LVGB (MD, -3.05; 95% CI, -5.88 to -0.21; n = 2 studies); the difference between RYGB and SG (n = 12 studies), BPD (n = 2 studies), gastric plication (n = 3 studies), and one anastomosis/gastric bypass (OAGB; n = 2 studies) did not reach statistical significance. Roux-en-Y gastric bypass was inferior to DS for BMI change (MD, 7.55; 95% CI, 6.35 to 8.75; 2 studies).

Park et al. (2019) conducted a systematic review with a network meta-analysis evaluating the comparative efficacy of various bariatric surgery techniques against standard-of-care in the treatment of morbid obesity and diabetes.¹³ The literature search was conducted through February 2018, identifying 45 RCTs for inclusion on RYGB (2 studies versus control), SG (3 studies versus control), LAGB (5 studies versus control), and biliopancreatic diversion (BPD) with DS (BPD-DS; 3 studies versus RYGB). Based on 33 trials, superior efficacy for percent excess weight loss (EWL) compared to standard-of-care was seen for BPD-DS (MD, 38.2%; 95% CI, 7.3 to 69.1), RYGB (MD 32.1%; 95% CI, 3.1 to 61.1), and SG (MD 32.5%; 95% CI, 5.5 to 59.5) at 6 months post-procedure. LAGB was not superior to standard-of-care (MD -0.2%; -19.6 to 19.2). At 3 years post-procedure, superior efficacy for percent EWL compared to standard-of-care was seen for RYGB (MD 45%; 95% CI, 21.8 to 68.2) and SG (MD 39.2%; 95% CI, 15.2 to 63.3). BPD-DS (relative risk [RR] 7.51; 95% CI, 1.91 to 29.54), RYGB (RR 7.51; 95% CI, 1.98 to 28.46), and SG (RR 6.69; 95% CI, 1.75 to 25.57) were all superior to standard-of-care with respect to remission rates at 3 to 5 years post-procedure and remission rates were not significantly different among procedures. SG was found to have a relatively lower risk of adverse events compared to RYGB.

Kang et al. (2017) conducted a systematic review with a network meta-analysis that compared the 3 most common types of bariatric surgery techniques: RYGB, SG and LAGB.¹⁴ The literature search, conducted through July 2016, identified 11 RCTs for inclusion (8 RYGB versus SG; 2 RYGB versus LAGB; 1 SG versus LAGB). Quality of the trials was assessed using the Jadad score, based on allocation concealment, blinding, intention-to-treat analysis, power calculation, and funding. Most trials had a Jadad score of 3 (scale range, 1 to 5). A meta-analysis for the outcome of BMI reduction (6 trials) showed that there was no difference between SG and RYGB (0.7; 95% CI, -1.6 to 3.1). A meta-analysis of RYGB and LAGB (2 trials) and a single trial of SG and LAGB showed that LAGB was not as effective as RYGB or SG (5.8; 95% CI, 2.3 to 9.1; and 5.1; 95% CI, 0.9 to 8.9; respectively). Meta-analyses for the outcome of percent EWL showed the same pattern, no difference comparing SG and RYGB (5 trials; -4.0; 95% CI, -14.0 to 8.2), and both SG and RYGB more effective than LAGB (2 trials; 22.0; 95% CI, 6.5 to 34.0; 1 trial; 26.0; 95% CI, 6.4 to 41.0; respectively).

Colquitt et al. (2014) updated 2003 and 2009 Cochrane reviews of bariatric surgery for obesity.¹⁵ The authors identified 22 randomized trials that compared bariatric surgery with nonsurgical obesity management or that compared different bariatric surgery procedures (N = 1,798 participants; sample size range, 15 to 250 participants). All 7 RCTs comparing surgery with nonsurgical interventions found benefits of surgery on measures of weight change at 1- to 2-year follow-ups. However, reviewers noted that adverse event rates and reoperation rates were poorly reported across trials, and long-term follow-up (beyond 1 to 2 years) was limited. Gloy et al. (2013) conducted a systematic review and meta-analysis of RCTs comparing current bariatric surgery techniques with nonsurgical treatment for patients with a BMI of 30 kg/m2 or more.¹⁶ Eleven studies (N = 796 patients) were included. Overall, patients after bariatric surgery lost more body weight than patients after nonsurgical treatment (MD, -26 kg; 95% CI, -31 to -21; p < .001). Remission of Type 2 diabetes (T2D) was more likely for bariatric surgery patients than for nonsurgical patients (RR of T2D remission, 22.1; 95% CI, 3.2 to 154.3; p < .000); similarly, remission of metabolic syndrome was more likely for bariatric surgery patients (RR, 2.4; 95% CI, 1.6 to 3.6; p < .001). After bariatric surgery, 21 (8%) of 261 patients required reoperations (5/124 after LAGB, 4/69 after RYGB, 1/49 after SG, 1/19 after BPD). Similar to the Colquitt et al. (2014) meta-analysis, no studies reported longer-term follow-up (> 2 years) and heterogeneity between studies were high. Chang et al. (2014) published a systematic review and meta-analysis of RCTs and observational studies to evaluate the effectiveness and risks of bariatric surgery.¹⁷ Reviewers included 164 studies (37 RCTs, 127 observational studies), with a total of 161,756 patients. Mean pre-surgery BMI was 45.62 kg/m² and, among the studies that provided information about obesity-related comorbidities, 26% of patients had T2D, 47% had hypertension, 28% had dyslipidemia, 7% had cardiovascular disease, and 25% had obstructive sleep apnea (OSA). Perioperative complications were relatively low, with a perioperative mortality rate in RCTs of 0.08% (95% CI, 0.01 to 0.24) and in observational studies of 0.22% (95% CI, 0.14 to 0.31). Complication rates were 17% (95% CI, 11 to 23) for RCTs and 10% for observational studies (95% CI, 7 to 13). At 1-year follow-up, mean change in BMI was -13.53 kg/m2 (95% CI, -15.51 to -11.55) in RCTs and -11.79 kg/m2 (95% CI, -13.89 to -9.69) in observational studies. Decreases in BMI were generally sustained over 2 to 4 years of follow-up among studies reporting this outcome.

Many systematic reviews have reported improvements in specific obesity-related comorbidities following bariatric surgery. These reviews have relied primarily on the results of observational studies and included the outcomes of hypertension, T2D, hyperlipidemia, cardiovascular events, quality of life, cancer, knee pain, and liver disease.^{18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37}

Liu et al. (2021) performed a network meta-analysis of 35 RCTs (N = 2198) to compare the effects of bariatric surgery versus lifestyle/medical interventions on dyslipidemia and insulin resistance in patients who are overweight with or without T2D.³⁸ Compared with lifestyle/medical interventions, the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR; a product of fasting circulating insulin and glucose concentrations divided by 22.5) was significantly lower with RYGB (MD, -3.93; 95% credible interval [CrI], -6.20 to -2.17), single anastomosis (mini-) gastric bypass (SAGB) (MD, -4.45; 95% CrI, -9.04 to -0.34), and SG (MD, -4.32; 95% CrI, -6.74 to -2.22). Compared with lifestyle/medical interventions, a statistically significant difference in the reduction of LDL-C was only reached with RYGB (MD, -0.51; 95% CrI, -0.85 to -0.16) and DS (MD, -0.90; 95% CrI, -1.66 to -0.16).

Wiggins et al. (2020) analyzed large-scale population studies to evaluate the association between bariatric surgery and long-term mortality and the incidence of new-onset obesity-related disease at a national level.³⁹ The analysis included 18 national or regional administrative database cohort studies involving patients who had undergone any bariatric procedure compared to an appropriate control group with a minimum follow-up of 18 months. Overall, 1,539,904 patients were included: 269,818 receiving a bariatric procedure and 1,270,086 controls. Results revealed that bariatric surgery was associated with a significant improvement in all-cause mortality (pooled odds ratio [POR], 0.62; 95% CI, 0.55 to 0.69; p < .001), cardiovascular mortality (POR, 0.5; 95% CI, 0.35 to 0.71; p < .001), T2D incidence (POR, 0.39; 95% CI, 0.18 to 0.83; p = .01), hypertension (POR, 0.36; 95% CI, 0.32 to 0.4; p < .001), dyslipidemia (POR, 0.33; 95% CI, 0.14 to 0.8; p = .01), and ischemic heart disease (POR, 0.46; 95% CI, 0.29 to 0.73; p = .001). Limitations of this analysis included inability to account for unmeasured variables, which may have not been equally distributed between patient groups due to the nonrandomized design of included studies, heterogeneity between studies regarding the nature of the control group utilized, and unexamined potential adverse effects related to bariatric surgery due to a lack of data.

Puzziferri et al. (2014) conducted a systematic review of studies of bariatric surgery reporting follow-up beyond 2 years, which included 29 studies (N = 7,971 patients).⁴⁰ At follow-up, which ranged from 2 to 5 years post-procedure, the mean sample size‒weighted percentage of EWL was higher for gastric bypass (65.7%) than for gastric banding (45.0%). Reviewers noted that few studies reported sufficient long-term results to minimize bias.

Section Summary: Bariatric Surgery in Adults With Morbid Obesity
There is a lack of large-scale RCTs with long-term follow-up comparing bariatric surgery with nonsurgical treatment for the general population of patients with morbid obesity. Evidence from nonrandomized comparative studies and case series and meta-analyses of existing RCTs has consistently reported that bariatric surgery results in substantially greater weight loss than nonsurgical therapy. Data from the largest comparative study (the SOS study) has reported that bariatric surgery is associated with improvements in mortality, diabetes, cardiovascular risk factors, and quality of life.

Evidence for Specific Types of Bariatric Surgery Procedures
Gastric Bypass for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of gastric bypass is to provide a treatment option that is an alternative to or an improvement on existing therapies, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does gastric bypass improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest are individuals who are adults with morbid obesity. Morbid obesity is defined as a BMI 40 kg/m² or more or a BMI 35 kg/m² or more with at least 1 clinically significant obesity-related disease such as diabetes, OSA, coronary artery disease, or hypertension for which these complications or diseases are not controlled by best practice medical management.

Interventions
The therapy being considered is gastric bypass. The procedure involves both a restrictive and a malabsorptive component, with the horizontal or vertical partition of the stomach performed in association with a Roux-en-Y procedure (i.e., a gastrojejunal); thus, food bypasses the duodenum and proximal small bowel.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are overall survival (OS), change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Negative outcomes can include surgical complications, including leakage and operative margin ulceration at the, and metabolic complications, including iron deficiency anemia, vitamin B12 deficiency, and hypocalcemia.

The existing literature evaluating gastric bypass as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 10 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 1-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up of 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Cui et al. (2021) published a systematic review of 7 RCTs comparing long-term outcomes of RYGB (n = 239) versus medical therapy (n = 238) in obese patients with T2D.⁴¹ Results demonstrated a higher likelihood of T2D remission with RYGB versus medical therapy at 1 year (RR, 18.01; 95% CI, 4.53 to 71.70), 3 years (RR, 29.58; 95% CI, 5.92 to 147.82), and 5 years (RR, 16.92; 95% CI, 4.15 to 69.00). The probability of achieving American Diabetes Association (ADA) treatment goals was also more likely with RYGB versus medical therapy at 1 year (RR, 3.99; 95% CI, 1.01 to 15.82), 3 years (RR, 3.16; 95% CI, 1.33 to 7.49), and 5 years (RR, 6.18; 95% CI, 1.69 to 22.68).

Yan et al. (2016) published a systematic review of RCTs comparing gastric bypass with medical treatment in obese patients (i.e., BMI ≥ 30 kg/m²) who had T2D.⁴² The primary study outcome was remission of T2D, which was reported in 5 of the 6 studies. A pooled analysis found a significantly higher remission rate after gastric bypass than after medical treatment (OR, 76.37; 95% CI, 20.70 to 271.73; p < .001). Also, a pooled analysis found a significantly lower final BMI in the gastric bypass group than in the medical treatment group (MD, -6.54 kg/m2; 95% CI, -9.28 to -3.80 kg/m2; p < .001).

A 2005 TEC Assessment focused on laparoscopic gastric bypass, which intends to reproduce the open procedure via minimally invasive techniques.⁴³ This technically complex surgery requires a dedicated team and a relatively high degree of skill and experience in laparoscopic technique. This Assessment reviewed 7 comparative trials of the open gastric bypass and laparoscopic gastric bypass, including 3 RCTs. Also, 18 large clinical series of laparoscopic gastric bypass were included. The Assessment concluded that weight loss at 1 year was similar for laparoscopic and open gastric bypass approaches.⁴³ Longer follow-up periods were less well-reported but appeared to be similar for both approaches. While comparisons of complication rates were less certain, some patterns were evident and consistent across the data examined. The profile of adverse events differed between the 2 approaches, with each having advantages and disadvantages. Laparoscopic gastric bypass offered a less invasive procedure associated with decreased hospital stay and earlier return to usual activities. Mortality might be lower with the laparoscopic approach, although both procedures had mortality rates less than 1%. Postoperative wound infections and incisional hernias were also less frequent with laparoscopic gastric bypass. However, anastomotic problems, gastrointestinal tract bleeding, and bowel obstruction appeared to be higher with the laparoscopic approach, though not markedly higher. Given these data, the overall benefit-risk profile for these 2 approaches appeared to be similar.

Observational Studies
Arterburn et al. (2021) published a retrospective, matched cohort study to investigate weight loss among patients with severe obesity undergoing RYGB, SG or nonsurgical treatment.⁴⁴ Among 17,258 RYGB, 13,900 SG, and 87,965 nonsurgical patients, the 5-year follow-up rate was 72.0%, 70.9%, and 64.5%, respectively. At 1, 5 and 10 years, RYGB patients had a %TWL of -28.35% (95% CI, -28.53 to -28.18), -21.74% (95% CI, -22.02 to -21.45), and -20.18% (95% CI, -21.00 to -19.34), respectively; at the same time points, nonsurgical patients had a %TWL of -0.22% (95% CI, -0.35 to -0.09), -2.24% (95% CI, -2.46 to -2.02), and -4.78% (95% CI, -5.51 to -4.04), respectively. At 1 and 5 years, SG patients had a %TWL of -22.98% (95% CI, -23.19 to -22.76) and -15.99% (95% CI, -16.58 to -15.40), respectively.

Wadden et al. (2019) reported on end-of-trial results from the Look AHEAD: Action for Health in Diabetes (Look AHEAD) trial, which evaluated outcomes in patients with T2D and obesity who had self-selected to receive bariatric surgery after failing an assigned intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) control therapy.⁴⁵ Patients who received bariatric surgery were significantly more likely to be female (p < .001), younger (p < .001), and have higher BMI at randomization (p < .001). Patients underwent 127 RYGB, 58 LAGB, and 11 SG procedures, respectively. End-of-trial assessments were completed at 4.3 years post-surgery compared to 9.6 years post-randomization for the DSE and ILI participants. Patients undergoing RYGB, LAGB, or SG surgical procedures lost a mean of 22.4% ± 1.0%, 13.0% ± 1.5%, and 16.2% ± 3.3% of baseline weight, respectively. Twelve patients (6.1%) receiving bariatric surgery were randomized with a BMI < 35 kg/m2. The mean BMI was 37.0 ± 5.1, 37.1 ± 5.3, and 42.1 ± 5.8 for DSE, ILI, and surgery groups, respectively (p < .001). Overall, surgically-treated patients lost a mean of 19.3% of baseline weight, compared with 5.8% and 3.3% for the ILI and DSE participants. Full diabetes remission was achieved by 7.6% of bariatric surgery participants compared to 1.1% of ILI and 1.1% of DSE participants. Full remission was significantly more common in surgically treated participants in ILI (RR 6.72; 95% CI, 3.35 to 13.48; p < .001) or DSE (RR 7.07; 95% CI, 3.49 to 14.30; p < .001) groups. Significantly greater reductions in waist circumference (p < .001), triglyceride levels (ILI: p = .03; DSE: p = .02), and hemoglobin A1c (HbA1c) levels (p < .001) were observed in surgically-treated patients compared to ILI or DSE groups. The study was limited by heterogeneity in baseline characteristics and choice of surgical procedure. Results were not stratified by surgery type or BMI range.

Section Summary: Gastric Bypass for Adults With Morbid Obesity
Gastric bypass has been extensively studied. TEC Assessments and other systematic reviews have found that gastric bypass improved health outcomes, including weight loss and remission of T2D. A TEC Assessment also found similar weight loss with open and laparoscopic gastric bypass.

Laparoscopic Adjustable Gastric Banding for Adults with Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of LAGB is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does the LAGB procedure improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is LAGB.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating LAGB as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 2 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 1-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up of 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
A 2006 TEC Assessment updated the evidence on LAGB and compared outcomes with gastric bypass.46, This Assessment concluded that, for patients considering bariatric surgery, there was sufficient evidence to permit an informed choice between gastric bypass and LAGB. An informed patient might reasonably choose open gastric bypass or LAGB as the preferred procedure. Preoperative counseling should include education on the comparative risks and benefits (eg, extent of weight loss and frequency and timing of potential complications) of the 2 procedures to optimize choice based on preferences and shared decision making.

Weight loss outcomes from the studies reviewed in the Assessment confirmed that weight loss at 1 year was lower for LAGB than for open gastric bypass. The percentage of EWL at 1 year was approximately 40%, compared with 60% or higher for open gastric bypass. At time points beyond 1 year, some comparative studies have reported that the difference in weight loss between LAGB and open gastric bypass narrows, but other studies did not. Weight loss outcomes from the 9 single-arm series with the most complete follow-up did not support the hypothesis that the difference in weight loss shrinks after 1 to 2 years of follow-up. It appears more likely from the current data that attrition bias might have accounted for the diminution of the difference in weight loss over time, particularly when patients with bands removed or deflated were excluded from analysis.

These studies also confirmed that short-term (perioperative) complications are very low with LAGB and lower than with open gastric bypass or LAGB. Death was extremely rare, and serious perioperative complications probably occurred at rates less than 1%. The reported rates of long-term adverse events vary considerably. In the comparative trials, reoperations were reported in approximately 25% of patients, while, in the single-arm studies, the composite rate for reoperations were approximately 50% lower (11.9%). The rates of other long-term complications were also highly variable; eg, the range of rates for band slippage was 1% to 36%, and the range for port access problems was 2% to 20%. These data on long-term complications remain suboptimal. The reporting of long-term complications in these trials was not systematic or consistent. While impossible to determine the precise rates of long-term complications from these data, it is likely that complications have been underreported in many studies due to incomplete follow-up and lack of systematic surveillance. A publication by Ibrahim et al. (2017) reviewed 25,042 Medicare beneficiaries who underwent LAGB surgery; 18.5% (n = 4636) patients underwent 1 or more reoperation(s). Reoperation was prompted by the need for band removal (41.8%), band and port replacement (28.6%), and other requirements.47, The rates of long-term complications reported in some studies raise concern about the impact of these events on the overall benefit-risk profile for LAGB.

In comparing LAGB with open gastric bypass, there are tradeoffs in terms of risks and benefits. LAGB is a less invasive procedure associated with fewer procedural complications, decreased hospital stay and earlier return to usual activities. However, benefits defined by the amount of weight lost are lower for LAGB. The patterns of long-term complications also differ between the 2 procedures. For LAGB, longer-term adverse events related to the presence of a foreign body in the abdomen will occur and result in reoperations and removal of the band in a minority of patients. Patients who have their bands removed can later be offered an alternative bariatric surgery procedure, such as gastric bypass.

A systematic review by Chakravarty et al. (2012)48, comparing LAGB with other bariatric surgery procedures drew conclusions similar to the TEC Assessment. Reviewers included 5 RCTs. The RCTs found that patients using LAGB lost weight, but less weight than with other procedures (e.g., gastric bypass or SG). However, the short-term complication rate was lower with LAGB, and no difference was found in quality of life after LAGB versus other procedures.

Prospective Studies
Dixon et al. (2018) published a prospective, industry-sponsored study of morbidly obese patients who underwent implantation of the adjustable gastric banding system (LAP-BAND)49,. Between 2009 and 2013, 652 patients with a mean BMI of 45.4 kg/m2 were treated at 17 participating centers in the United States and Canada. At 5 years, the explant rate was 8.74% (95% CI, 6.6 to 10.9). Excluding explants, 100 (15.3%) reoperations were necessary during the follow-up period. A mean weight loss of 18.7% was achieved by 2 years and maintained through 5-year follow-up. The study was limited by the lack of control group.

Section Summary: Laparoscopic Adjustable Gastric Banding for Adults With Morbid Obesity
Systematic reviews of the literature have concluded that there is less weight loss with LAGB than gastric bypass.

Sleeve Gastrectomy for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of SG is to provide a treatment option that is an alternative to or an improvement of existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does SG improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is SG, an alternative approach to gastrectomy that can be performed on its own or in combination with malabsorptive procedures. In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or sleeve. This procedure can be done as an open or laparoscopic procedure.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating SG as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 5 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up of 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Sleeve gastrectomy may be performed as a stand-alone procedure or in combination with a malabsorptive procedure, such as the BPD with BPD-DS. It has also been proposed as the first step in a 2-stage procedure, with gastric bypass or BPD as the second stage.

Numerous recent systematic reviews have compared SG and RYGB with regard to effects on weight, comorbidities, and complications.^{50,51,52,53,54,55}

Lee et al. (2021) performed a meta-analysis evaluating long-term (5 years) outcomes of laparoscopic RYGB versus SG (Table 4).⁵⁶ A total of 33 studies (N = 2,475) were included. Results demonstrated that RYGB resulted in a significantly greater decrease of BMI compared to SG at 1 and 3 years post-surgery; results at 5 years did not reach statistical significance (Table 5). A similar trend was seen for the resolution of dyslipidemia. Furthermore, neither RYGB nor SG was superior for the remission of T2D and hypertension at 5 years.

Gu et al. (2020) completed a meta-analysis of the medium- and long-term effects of laparoscopic SG and RYGB (Table 4).⁵⁰ The evaluation included 9,038 patients from 28 studies. Overall, 5 year follow-up results revealed that laparoscopic RYGB was associated with an improvement in percentage of EWL and remission of T2D, hypertension, and dyslipidemia as compared to laparoscopic SG. Han et al. (2020) also published a systematic review and meta-analysis involving 18 studies (N = 2,917) that compared weight loss and comorbidity resolution between laparoscopic SG and RYGB (Table 4).⁵¹ Results from this analysis revealed no significant difference in EWL or T2D resolution between the 2 procedures. Laparoscopic RYGB was found to be superior to SG with regard to dyslipidemia, hypertension, and GERD management; however, patients who underwent laparoscopic SG experienced fewer postoperative complications and reoperation rates.

Sharples et al. (2020) performed a systematic review and meta-analysis evaluating long-term (5 years) outcomes of RYGB and SG (Table 4).52, Overall, both RYGB and SG resulted in sustained weight loss and comorbidity control with RYGB associated with a greater percent EWL, improved dyslipidemia outcomes, and a reduced incidence of GERD (Table 5).

Shenoy et al. (2020) published a systematic review and meta-analysis of 9 studies that compared laparoscopic SG and RYGB in 2240 elderly (> 55 years) patients.⁵³ Results revealed no significant differences between the 2 bariatric procedures with regard to the rate of early complications (3.6% LSG versus 5.8% LRYGB; p = .15) and mortality (0.1% versus 0.8%; p = .27). Additionally, there was no difference in EWL between the procedures at 1 year (Table 5); however, the authors recommended SG for high-risk elderly patients due to the reduced mortality and complication rates with this procedure. Another systematic review and meta-analysis by Xu et al. (2020) involving 19 studies also concluded that SG was the preferable option for elder obese patients 60 years and older as it was found to be non inferior to RYGB with regard to efficacy, but overall had an improved safety profile.⁵⁷

Osland et al. (2017) published a systematic review and meta-analysis of RCTs comparing laparoscopic vertical SG with RYGB (Table 4).⁵⁸ The literature search, conducted from 2000 to November 2015, identified 9 RCTs for inclusion (N = 865 patients). Four trials were included in meta-analyses comparing percent EWL between the 2 groups. Results at both 6- and 12-month follow-ups showed that the procedures are comparable (Table 5). Osland et al. (2020) recently published a continuation of their work that focused exclusively on long-term (5 year) weight outcomes of laparoscopic vertical SG versus RYGB.⁵⁹ This systematic review and meta-analysis included 5 studies (SG = 520; RYGB = 508) and results revealed that a statistically significant BMI loss was seen with both SG: -11.37 kg/m2 (range: -6.3 to -15.7 kg/m2) and RYGB: -12.6 kg/m2 (range: -9.5 to -15.4 kg/m2) at 5 years. However, differences in reporting parameters limit the ability to reliably compare outcomes using statistical methods and the results may have been impacted by large dropout rates and per protocol analyses of the 2 largest included studies.

A systematic review by Juodeikis and Brimas (2017) summarized evidence on long-term results after SG (Table 3).⁶⁰ Reviewers included an RCT and 19 retrospective studies, with a total of 2,713 patients who received SG. Mean preoperative BMI was 46.9 kg/m². Mean duration of follow-up ranged from 5 to 11 years, and mean proportion of patients followed for 5 years was 68.5%. Seventeen studies (N = 1,501 patients) reported 5-year follow-up data. At 5 years, resolution of T2D, arterial hypertension, dyslipidemia, OSA, gastroesophageal reflux disease (GERD), and degenerative joint diseases also improved in most patients (Table 5). Two studies reported weight loss after 7 and 8 years; percent EWL rates were 56.6% and 54.8%, respectively.

In a meta-analysis of 21 randomized and nonrandomized studies (N = 18,766 patients) comparing SG with laparoscopic RYGB for morbid obesity, Zhang et al. (2015) reported no significant difference in percent EWL from 0.5- to 1.5-year follow-ups (Tables 3 and 4).⁶¹ However, after 1.5 years, RYGB was associated with higher percent EWL (2-year MD, 5.77; 95% CI, 4.29 to 7.25; p < .05). Adverse events were more frequent following RYGB (OR for major complication, 1.29; 95% CI, 1.22 to 3.22; p < .01).

Trastulli et al. (2013) conducted a systematic review of 15 RCTs (N = 1,191 patients) that compared SG with other bariatric procedures (Table 4).⁶² Summary statistics were provided; meta-analyses were not conducted (Table 5). Reviewers reported mean complication rates with SG of 12.1% (range, 10% to 13.2%) compared with 20.9% with LAGB (range, 10% to 26.4%). Percent EWL ranged from 49% to 81% with SG and from 62.1% to 94.4% with LAGB.

Brethauer et al. (2009) reviewed 36 studies (N = 2,570 patients) in a systematic review of SG as a staged and primary procedure, the largest trials coming from European centers (Table 4).⁶³ Thirteen studies (n = 821 patients) reported on high-risk patients having a staged approach and 24 studies (n = 1,749 patients) on SG as the primary procedure. Mean percent EWL, reported in 24 studies (n = 1,662 patients), was 55.4% overall. Mean postoperative BMI, reported in 26 studies (n = 1,940 patients), decreased from a baseline of 51.2 to 37.1 kg/m². Other studies reported weight loss in terms of BMI decrease, the percentage of BMI lost, or percentage of total weight lost; all had significant reductions from baseline. Rates of major postoperative complications ranged from 0% to 23.8% for all studies and from 0% to 15.3% in studies with more than 100 patients. Leaks (2.2%), bleeding episodes requiring reoperation (1.2%), and postoperative strictures requiring endoscopic or surgical intervention (0.6%) were reported in the 33 studies (n = 2,570 patients). All extracted studies reported mortality data, with 5 deaths within 30 days of surgery (overall mortality rate, 0.19%; 2 in the high-risk/staged group, 3 in the primary procedure group).

Table 4. Systematic Review Characteristics for Sleeve Gastrectomy

Study	Dates	Studies	Participants	Design	Duration
Lee et al. (2021) 56	Through Jan 2019	33	SG = 1252; RYGB = 1223	RCTs	1 to 5 y
Gu et al. (2020)50	Through Jan 2019	28	SG = 4597; RYGB = 4441	7 RCTs; 6 prospective; 15 retrospective	3 to 7 y
Han et al. (2020)51	Through Jan 2020	18	2917	9 RCTs; 9 nonrandomized studies of interventions	1 to 82.2 mo
Sharples et al. (2020)52	Through Dec 2018	5	729	RCTs	5 y
Shenoy et al. (2020)53	1991 to 2019	9	SG = 683; RYGB = 1557	RCTs; observational studies	Minimum follow-up: 1 y
Osland et al. (2017)58	2000 to Nov 2017	9	SG = 437; RYGB = 428	RCTs	3 mo to 5 y
Juodeikis et al. (2017)60	Through May 2016	20	1626	1 RCT; 19 retrospective	5 to 11 y
Zhang et al. (2015)61	Through Oct 2013	21	18,766	8 RCTs; 13 nonrandomized comparative	1 to 5 y
Trastulli et al. (2013)62	Through Nov 2012	15	1191	RCTs	6 mo to 3 y
Brethauer et al. (2009)63	1996 to 2009	36	2570	2 RCTs; 1 cohort; 33 case series	3 mo to 5 y

RCT: randomized controlled trial; RYGB: Roux-en-Y gastric bypass; SG: sleeve gastrectomy.

Table 5. Systematic Review Results for Sleeve Gastrectomy

Study	BMI mean difference (95% CI)	Comorbidities (95% CI)
Lee et al. (2021)56	Mean difference SG vs RYGB: 1 y (16 trials): -1.25 kg/m2 (-2.01 to -0.49) 3 y (5 trials): -1.71 kg/m2 (-2.68 to -0.74) 5 y (4 trials): -1.46 kg/m2 (-3.15 to 0.23)	Remission, SG vs RYGB: T2D (1 y): RR, 0.86 (0.71 to 1.04) T2D (3 y): RR, 0.88 (0.72 to 1.07) T2D (5 y): RR, 0.79 (0.57 to 1.10) Hypertension (5 y): RR, 0.86 (0.68 to 1.10) Dyslipidemia (5 y): RR, 0.68 (0.46 to 1.23)
	Percent EWL (95% CI)	Comorbidities (95% CI)
Gu et al. (2020)50	Weighted mean difference, RYGB and SG: 3 y (13 trials): -4.37 (-8.10 to -0.64) 5 y (9 trials): -2.20 (-3.83 to -0.57)	Remission, RYGB and SG: T2D (3 y): OR, 0.68 (0.48 to 0.95) T2D (5 y): OR, 0.63 (0.41 to 0.96) Hypertension (5 y): OR, 0.51 (0.38 to 0.68) Dyslipidemia (5 y): OR, 0.3 (0.19 to 0.48)
Han et al. (2020)51	Mean difference, RYGB and SG: RCTs: -0.16 (-0.52 to 0.19)	Resolution, RYGB and SG: T2D: RR, 1.07 (0.89 to 1.28) Dyslipidemia: RR, 1.36 (1.17 to 1.59) Hypertension: RR, 1.23 (1.04 to 1.45) GERD symptoms: RR, 0.16 (0.06 to 0.44)
Sharples et al. (2020)52	5 y: RYGB: 65.7% SG: 57.3%	RYGB vs. SG at 5 y: T2D resolution: 37.4% vs. 27.5% Diabetes improvement: 77.5% vs. 74% Hypertension resolution: 60.1% vs. 48.4% Hypertension improvement: 86.4% vs. 76.6% Dyslipidemia resolution: 68.6% vs. 55.2% GERD remission: 60.4% vs. 25%
Shenoy et al. (2020)53	Mean difference, RYGB and SG: -7.79 (-23.96 to 8.38)	Resolution, RYGB and SG: T2D (5 studies): OR, 1.02 (0.63 to 1.66) Hypertension (4 studies): OR, 0.57 (0.35 to 0.93) Obstructive sleep apnea (2 studies): OR, 1.14 (0.55 to 2.34)
Osland et al. (2017)58	Mean difference, SG and RYGB: 6 mo (3 trials): 0.5 (-5.0 to 6.0) 12 mo (2 trials): 7.6 (-0.1 to 15.3)	NR
Juodeikis et al. (2017)60	Mean rates for SG: 5 y (17 trials): 58.4% 7 y (2 trials): 56.6% 11 y (1 trial): 62.5%	Remission/improvement: T2D: 77.8% Hypertension: 68.0% Dyslipidemia: 65.9% Sleep apnea: 75.8%
Zhang et al. (2015)61	Mean difference, RYGB and SG: 6 mo (9 studies): 0.2 (-2.5 to 2.9) 12 mo (15 studies): 2.9 (-0.2 to 6.0) 4 y (3 studies): 2.7 (0.2 to 5.2)	Mean difference resolution, RYGB and SG: T2D (10 studies): 3.3 (2.0 to 5.5) Hypertension (10 studies): 1.3 (0.7 to 2.4) Dyslipidemia (5 studies): 1.1 (0.3 to 1.3) Sleep apnea (7 studies): 1.5 (0.8 to 2.6)
Trastulli et al. (2013)62	Mean by procedure: SG: 49% to 81% LGB: 62% to 94% LAGB: 29% to 48%	T2D: SG, 67% to 100% LGB, 80% to 100%
Brethauer et al. (2009)63	Mean rate overall for SG: 55% (range, 33% to 85%)	Remission/improvement: T2D: > 70% Significant reductions also seen in hypertension, hyperlipidemia, and sleep apnea

BMI: body mass index; CI: confidence interval; EWL: excess body weight loss; GERD: gastroesophageal reflux disease; LAGB: laparoscopic adjustable gastric banding; LGB: laparoscopic gastric bypass; NR: not reported; OR: odds ratio; RCT: randomized controlled trial; RR: relative risk; RYGB: Roux-en-Y gastric bypass; SG: sleeve gastrectomy; T2D: type 2 diabetes.

Randomized Controlled Trials
Hofso et al. (2019) published the results of a single-center, triple-blind RCT comparing the efficacy of RYGB (n = 54) versus SG (n = 55) on diabetes remission and ß-cell function in patients with obesity and T2D.⁶⁴ Inclusion criteria included previously verified BMI ≥ 35 kg/m2 and current BMI ≥ 33.0 kg/m2, HbA1c ≥6.5% or use of antidiabetic medications with HbA1c ≥6.1%, and age ≥18 years. One-year follow-up was completed by 107 (98%) of 109 patients, with 1 patient in each group withdrawing after surgery. In the intention-to-treat population, diabetes remission rates were superior in the gastric bypass group than in the SG group (risk difference 27%; 95% CI, 10 to 44; RR 1.57, 95% CI, 1.14 to 2.16; p = .0054). Results were similar in the per-protocol population (risk difference 27%; 95% CI, 10 to 45; RR 1.57; 95% CI, 1.14 to 2.15; p = .0036). The 2 procedures had a similar beneficial effect on ß-cell function.

Peterli et al. (2018) published a randomized study of adults with morbid obesity treated with either laparoscopic SG (LSG) or RYGB.65, Two hundred five patients (mean age, 45.5 years; mean BMI, 43.9; 72% women) treated at 4 Swiss bariatric centers were randomly assigned to receive SG (n = 101) or RYGB (n = 104) with 5-year follow-up. Excess BMI loss was 61.6% for SG and 68.3% for RYGB (95% CI, -14.30 to -0.06; p = .22). Gastric reflux remission was seen in 25.0% of SG and 60.4% of RYGB patients. Reoperations or interventions were necessary for 16/101 (15.8%) in the SG group and 23/104 (22.1%) of the RYGB group. The study was limited by the lack of analysis of diabetes remission information, and the results may not be generalizable.

Salminen et al. (2018) published a randomized trial, Laparoscopic Gastric Bypass vs. Laparoscopic Sleeve Gastrectomy in the Treatment of Morbid Obesity (SLEEVEPASS), comparing 5-year outcomes of morbidly obese patients (n = 240; mean age, 48 years; mean baseline BMI, 45.9; 69.6% women) who underwent either LSG (n = 121) or RYGB (n = 119).66, Five-year estimated mean percentage excess BMI losswas 49% (95% CI, 45 to 52) for SG and 57% (95% CI, 53 to 61) for gastric bypass. For SG and RYGB, respectively, rates of remission of T2D were 37% (n = 15/41) and 45% (n = 18/40; p>0.99). Medication for hypertension was discontinued in 20/68 (29%) SG patients and 37/73 (51%) RYGB patients (p = .02). Overall 5-year morbidity rate was 19% for SG and 26% for RYGB (p = .19), and there was no significant difference in quality of life between groups (p = .85). The study was limited by the following: (1) only a small number (n = 430) of bariatric procedures were performed in Finland at trial initiation in 2008, meaning a learning curve could account for some earlier technical complications, (2) the study had a higher reoperation rate for SG than other trials reported, (3) approximately 20% of patients were lost to follow-up, and (4) there was a lack of reliable information for diabetes duration at baseline.

Wolnerhanssen et al. (2021) pooled 5-year outcomes data from the 2018 studies by Peterli et al. and Salminen et al.67, Five-year follow-up was available for 199 of 228 patients after SG and 199 of 229 after RYGB. Patients who underwent SG had an estimated 7% greater excess BMI loss versus RYGB (p < .001). While remission rates for hypertension were better after RYGB versus SG (60.3% vs 44.9%; p < .049), between-group differences in rates of remission of T2D, OSA, or quality of life scores did not reach statistical significance. The rate of complications was higher after RYGB versus SG (37.2% vs 22.5%; p = .001), but there was no difference in mean Comprehensive Complication Index value (30.6 vs 31.0 points; p = .859).

An RCT comparing short-term outcomes of laparoscopic SG with gastric bypass was published in 2012.68, Trialists compared 30-day outcomes for 117 patients randomized to gastric bypass with 121 patients randomized to LSG. The rate of major complications (no deaths in either group) was 9.4% in the gastric bypass group compared with 5.8% in the LSG group (p = .29). Minor complications were more common in the gastric bypass group than in the LSG group (17.1% versus 7.4%, p = .02), as were combined major and minor complications (26.5% versus 13.2%, p = .01).

Karamanakos et al. (2008) carried out a double-blind RCT comparing outcomes of laparoscopic RYGB and LSG on body weight, appetite, fasting, and postprandial ghrelin and peptide YY (levels at 1, 3, 6, and 12 months after surgery).69, Thirty-two patients were randomized, half to each procedure. The decrease in body weight and BMI were marked and comparable in each group. EWL was greater after LSG than laparoscopic RYGB at 6 months (55.5% versus 50.2%; p = .04) and 12 months (69.7% versus 60.5%; p = .05), all respectively. Fasting peptide YY levels increased after both surgical procedures. Appetite decreased in both groups but decreased more after LSG.

Himpens et al. (2006) reported on a randomized trial comparing LAGB with isolated LSG in 80 patients and reported 3-year follow-up.70, Median baseline BMI was 37 kg/m2 (range, 30 to 47 kg/m2) in the LAGB group and 39 kg/m2 (range, 30 to 53 kg/m2) in the SG group. Outcomes of weight loss, feeling of hunger, sweet-eating, GERD, complications, and reoperations were recorded at 1- and 3-year follow-ups. Median decrease in BMI in the gastric bypass group was 15.5 kg/m2 (range, 5 to 39 kg/m2) after 1 year and 18 kg/m2 (range, 0 to 39 kg/m2) at 3 years after LAGB. One year after SG, decrease in BMI was 25 kg/m2 (range, 0 to 45 kg/m2) and 27.5 kg/m2 (range, 0 to 48 kg/m2) after 3 years. Median EWL in the LAGB group was 41.4% after 1 year and 48% at 3 years. Median EWL after SG was 58% and 66% at 1 and 3 years, respectively. More patients having SG than LAGB reported a loss of craving for sweets, but the difference was not statistically significant; GERD appeared de novo in more SG than LAGB patients at 1 year, and the relation reversed at 3 years; between-group differences were not statistically significant at either time point. Two SG patients required reoperation for complications. Seven late complications required reoperation after LAGB, including pouch dilations treated by band removal (n = 2) or conversion to RYGB (n = 1), 1 gastric erosion treated by conversion to RYGB, and 3 system disconnections that required reconnection. Four patients had reoperations for lack of efficacy (2 LAGB patients underwent conversion to RYGB, 2 SG patients underwent conversion to DS). The trialists noted that the number of reoperations was significant in both groups and that the severity of complications was greater in the SG group.

Section Summary: Sleeve Gastrectomy for Adults with Morbid Obesity
Systematic reviews of RCTs and observational studies, evaluating SG alone and comparing SG with RYGB, have found that SG results in substantial weight loss, comparable to RYGB and that this weight loss is durable for at least 5 years. A meta-analysis found that short-term weight loss was similar after SG or gastric bypass. Long-term weight loss was greater after gastric bypass, but SG is associated with fewer adverse events.

Biliopancreatic Diversion With Duodenal Switch for Adults with Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of BPD-DS is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does the BPD-DS procedure improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is BPD-DS. BPD may be performed with or without the DS procedure. In the BPD-DS, a SG is performed, preserving the pyloric sphincter. Preservation of the pyloric sphincter is intended to ameliorate dumping syndrome and to decrease the incidence of ulcers at the duodeno-ileal junction by providing a more physiologic transfer of stomach contents to the duodenum.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating BPD-DS as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 15 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Review
In an evidence-based review of literature, Farrell et al. (2009) summarized data on BPD with or without DS, RYGB (proximal), and LAGB, and reported that at a mean 1-year follow-up, EWL for BPD with or without DS (outcomes with and without DS not reported separately) was 72% (4 studies; n = 896 patients), 67% for RYGB (7 studies; n = 1,627 patients), and 42% for LAGB (11 studies; n = 4,456 patients).⁷¹ At mean follow-up of 5 years, EWL for BPD with or without DS was 73% (3 studies; n = 174 patients), 58% for RYGB (3 studies; n = 176 patients), and 55% for LAGB (5 studies; n = 640 patients). Reviewers noted that “given the marked paucity of prospectively collected comparative data among the different bariatric operations, it remains impossible to make definitive recommendations for one procedure over another.”

Nonrandomized Comparative Studies
Skogar et al. (2017) published results from a retrospective mail survey of patients undergoing BPD-DS (n = 113) or RYGB (n = 98) (Table 6).⁷² Reduction in BMI was statistically larger in patients receiving BPD-DS compared with patients receiving RYGB. Both groups experienced significant reductions in diabetes and OSA. Significant reductions in dyslipidemia were only seen in the group receiving BPD-DS. The overall complication rate was lower for patients undergoing RYGB.

Strain et al. (2007) published a comparative study of 72 patients who underwent RYGB (n = 50) or BPD (n = 22) (Table 6).⁷³ Choice of surgery was by the surgeon and/or patient, and the patient populations differed by age and time since surgery. Weight loss at 1 year was greater for BPD, with a reduction in BMI of 10.6 kg/m2 (23.3 lb) for BPD compared with 7.5 kg/m2 (16.5 lb) for RYGB (p < .001).

Prachand et al. (2006) published the largest comparative study of 350 super-obese patients with a BMI greater than 22.7 kg (50 lb) who underwent RYGB (n = 152) or Scopinaro BPD combined with the DeMeester BPD-DS (n = 198) (Table 6).⁷⁴ In this retrospective study, the decision for surgery was made by the surgeon and/or patient. The BPD-DS patients differed from RYGB patients on baseline weight and BMI; mean weight was 167 kg (368 lb; range, 267 to 597 lb) in BPD-DS patients and 157 kg (346 lb; range, 240 to 505 lb) in the RYGB group, and mean BMI was 27 kg/m2 (59 lb; range, 50 to 96 lb) in BPD-DS patients versus 26 kg/m2 (56 lb; range, 50 to 84 lb) in the RYGB group. At 1 year, data were reported for 143 BPD-DS patients and 81 RYGB patients (Table 7). EWL was greater for BPD (64.1%) versus RYGB (55.9%; p < .01), and the reduction in BMI was also greater with BPD (10.7 kg/m2 [23.6 lb]) versus RYGB (8.8 kg/m2 [19.4 lb]; p < .001). Complications and data on the resolution of comorbidities were not reported.

Table 6. Nonrandomized Comparative Study Characteristics for Biliopancreatic Diversion With Duodenal Switch

Study	Country	Dates	Participants	Follow-Up
Skogar et al. (2017)72	Sweden	2003 – 2012	BPD-DS: 113 RYGB: 98	4 y
Strain et al. (2007)73	U.S.	2002 – 2005	BPD-DS: 22 RYGB: 50	BPD-DS: 19 mo RYGB: 15 mo
Prachand et al. (2006)74	U.S.	2002 – 2005	BPD-DS: 198 RYGB: 152	3 y

BPD-DS: biliopancreatic diversion with duodenal switch; RYGB: Roux-en-Y gastric bypass.

Table 7. Nonrandomized Comparative Study Results for Biliopancreatic Diversion With Duodenal Switch

Study	Mean Reduction in BMI (SD)		Percent Achieving ≥50% EWL
	Presurgery, kg/m2	Postsurgery, kg/m2	pa	1 Year	2 Years	3 Years
Skogar et al. (2017)72 BPD-DS RYGB	56 (6.7) 52 (4.0)	31 (5.5) 36 (7.1)	< 0.01	NR NR
Strain et al. (2007)73 BPD-DS RYGB			< 0.01	NR NR
		Change in BMI
Prachand et al. (2006)74 BPD-DS RYGB	59 (6.7) 56 (6.8)	27.8 18.9	< 0.01	83.9 70.4b	89.2 79.3	84.2 59.3b

BMI: body mass index; BPD-DS: biliopancreatic diversion with duodenal switch; EWL: excess weight loss; NR: not reported; RYGB: Roux-en-Y gastric bypass; SD: standard deviation.
^a Between groups, difference in change.
^b p < .05.

Case Series
Strain et al. (2017) reported on the nutrient status of 190 patients receiving BPD-DS after 9 years of follow-up.⁷⁵ At baseline, the patients had a mean age of 43 years and mean BMI of 53 kg/m². All patients reported taking some supplements. Deficiencies in protein, iron, and calcium developed by year 3 and continued through the study. Zinc deficiencies developed by year 5. Folate levels increased during the study, probably due to the efficacy of the supplement. The authors warned that interventions need to be implemented to improve nutrient status in patients receiving BDP-DS.

The largest case series of this procedure is by Marceau et al. (2009), who reported on their 15-year experience with DS in 1423 patients from 1992 to 2005.⁷⁶ Follow-up evaluations were available for 97% of patients. Survival rate was 92%. After a mean of 7 years (range, 2 to 15 years), 92% of patients with an initial BMI of 50 kg/m² or less obtained a BMI of 35 kg/m² or less, and 83% of patients with a BMI greater than 50 kg/m2 achieved a BMI of less than 40 kg/m². Diabetes medication was discontinued in 92% and decreased in others. Use of continuous positive airway pressure was discontinued in 92% of patients, and the prevalence of cardiac risk index greater than 5 decreased by 86%. Operative mortality was 1%, the revision rate was 0.7%, and the reversal rate was 0.2%. Revision for failure to lose sufficient weight was needed in only 1.5% of patients. Severe anemia, vitamin deficiency, or bone damage were preventable or easily treated and without documented permanent damage.

Section Summary: Biliopancreatic Diversion With Duodenal Switch for Adults With Morbid Obesity
Nonrandomized comparative studies have found significantly higher weight loss after BPD-DS compared with gastric bypass at 1 year. A large case series found sustained weight loss after 7 years.

Biliopancreatic Diversion without Duodenal Switch for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of BPD without DS is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does the BPD without DS procedure improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is BPD without DS.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating BPD without DS as a treatment for morbid obesity has varying lengths of follow-up, ranging to 9 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up of 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Review
The available evidence on BPD-DS was reviewed in the 2006 TEC Assessment, and BPD outcomes, with or without DS, were compared with those of gastric bypass.⁴⁶ One comparative trial and 7 single-arm series suggested that weight loss outcomes at 1 year were in the same range as for gastric bypass. While these data were not sufficient to distinguish small differences in weight loss between the 2 procedures, they did not support the hypothesis that BPD resulted in greater weight loss than open gastric bypass.

Randomized and Nonrandomized Studies
Complication rates have been poorly reported in these trials. The data have suggested that mortality is low (1%) and in the same range as for open gastric bypass. However, rates of other complications, especially long-term complications, cannot be determined from these data. Limited data have suggested that long-term nutritional and vitamin deficiencies occur at a high rate following BPD. Slater et al. (2004) focused specifically on vitamin and calcium deficiencies following BPD.⁷⁷ The authors reported high rates of vitamin and calcium abnormalities in their population over a 4-year period. By year 4, 48% of patients had low calcium, and 63% had low levels of vitamin D. Other fat-soluble vitamins showed similar patterns of abnormalities. Low vitamin A was found in 69% of patients at 4 years, low vitamin K in 68%, and low zinc in 50%. Dolan et al. (2004) reported similar data in a study that compared several technical variations of BPD.⁷⁸ The authors reported low calcium levels in 12% to 34% of patients, low vitamin D in 22.2% to 70.6%, low vitamin A in 53% to 67%, and low vitamin K in 44% to 59%. Also, this study reported high rates of iron deficiency (11% to 47%) and anemia (11% to 40%).

Skroubis et al. (2006) randomized 130 patients with a BMI of 35 to 50 kg/m² to RYGB or BPD without DS using a variant of BPD that included RYGB in place of SG.⁷⁹ All patients were followed for at least 2 years. Weight loss outcomes were superior for the BPD group at every interval examined up to 2 years. EWL at 1 year was 73.7% for RYGB and 83.1% for BPD (p < .001); at 3 years, EWL was 72.6% for RYGB and 83.1% for BPD (p < .001). There were more early complications in the RYGB group, but this difference was not statistically significant (6 complications versus 1, respectively; p = .12). Late complications also did not differ significantly between the RYGB group (16 complications) and BPD groups (22 complications; p = .46).

Case Series
Numerous clinical series of BPD have been published but high-quality trials directly comparing outcomes of this procedure with gastric bypass are lacking. The largest experience with BPD (N = 1,217 patients) was reported by Scopinaro et al. (1996), who developed the procedure.⁸⁰ With a follow-up of up to 9 years, the authors reported a durable EWL of 75%, suggesting that weight loss is greater with this procedure than with gastric restrictive procedures. Also, most patients reported disappearance or improvement of complications such as OSA, hypertension, hypercholesterolemia, and diabetes. The authors considered protein malnutrition to be the most serious metabolic complication, occurring in almost 12% of patients and responsible for 3 deaths. This complication could require inpatient treatment with total parenteral nutrition. To address protein malnutrition, 4% of patients underwent reoperation to elongate the common limb (thus increasing protein absorption) or to have the operation reversed, restoring normal intestinal continuity. The authors also found that protein malnutrition was strongly related to ethnicity and, presumably, patient eating habits, with an increased incidence among those from southern Italy where the diet contains more starch and carbohydrates than the north. Peripheral neuropathy may occur in the early postoperative period due to excessive food limitation but may be effectively treated with large doses of thiamine. Bone demineralization, due to decreased calcium absorption, was seen in about 33% of patients during the first 4 postoperative years. All patients were encouraged to maintain an oral calcium intake of 2 g/d, with monthly vitamin D supplementation.

Section Summary: Biliopancreatic Diversion without Duodenal Switch for Adults With Morbid Obesity
A TEC Assessment reviewed the available observational studies and concluded that weight loss was similar after BPD without the DS and gastric bypass. However, BPD without DS leads to complications, especially long-term nutritional and vitamin deficiencies.

Vertical-Banded Gastroplasty for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of VBG is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does the VBG procedure improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is VBG. In this procedure, the stomach is segmented along its vertical axis, a plug of the stomach is removed, and a propylene collar is placed through this hole and then stapled to itself. It can be performed using an open or laparoscopic approach.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Negative outcomes associated with VBG include complications such as esophageal reflux, dilation, or obstruction of the stoma.

The existing literature evaluating VBG as a treatment for morbid obesity has varying lengths of follow-up, ranging from 3 to 10 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 3 to 10 years of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Hseih et al. (2014) conducted a systematic review of studies reporting greater than 10-year follow-up for VBG, which included 3 studies with extractable data.⁸¹ Mean EWL was 61.4% from baseline to follow-up in the 3 studies, but reviewers noted a lack of long-term evidence related to outcomes following VBG.

A number of nonrandomized, comparative studies of open gastric bypass versus VBG were included in the 2003 TEC Assessment (N = 8 studies, total N = 3,470 patients).⁸² All 8 studies reported greater amounts of weight loss with open gastric bypass. These studies reported a 44% to 70% improvement in TWL, a 28% to 43% improvement in the percent EWL, and 19% to 36% more patients with more than 50% EWL for those undergoing gastric bypass compared with VBG. Comparison of adverse events was difficult because the data did not permit rigorous assessment. Nevertheless, the data suggested that the mortality rate for both surgeries was low overall. Serious perioperative adverse events were also infrequently reported, but somewhat higher for gastric bypass. Long-term adverse events were inconsistently reported, although it appeared that revision rates were higher for VBG.

Randomized Controlled Trials
A small body of literature has compared outcomes between VBG and open gastric bypass. The most rigorous of these comparative trials, the Adelaide Study (1990), randomized 310 morbidly obese patients to gastric bypass, VBG, or horizontal gastroplasty.⁸³ The percentage of patients with greater than 50% EWL at 3-year follow-up was 67% for gastric bypass, 48% for VBG, and 17% for horizontal gastroplasty (p < .001). There were no demonstrable differences in adverse events across groups.

A second, smaller RCT by Sugerman et al. (1987) randomized 40 patients to a VBG or a gastric bypass procedure.⁸⁴ After 9 months, the gastric bypass patients had significantly greater weight loss that was maintained at 3-year follow-up. The gastric bypass patients lost approximately 64% of excess weight, whereas the gastroplasty patients lost 37% of excess weight.

Case Series
Relatively high rates of complications, revisions, and reoperations led to the abandonment of VBG as a bariatric surgery procedure in the United States. An example of these results is a large case series with long-term follow-up by MacLean et al. (1990), who reported on 201 patients undergoing VBG followed for a minimum of 2 years.⁸⁵ Staple line perforation occurred in 48% of patients, and 36% underwent reoperation either to repair the perforation or to repair a stenosis at the rate-limiting orifice. However, the more than 50% of patients who maintained an intact staple line had a durable weight loss of 75% to 100% of excess weight.

Section Summary: Vertical-Banded Gastroplasty for Adults With Morbid Obesity
A TEC Assessment identified 8 nonrandomized comparative studies evaluating VBG with gastric bypass. The assessment found that weight loss was significantly greater with open gastric bypass than with VBG. Also, VBG has relatively high rates of complications, revisions and reoperations.

Two-Stage Bariatric Surgery Procedures for Adults with Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of 2-stage bariatric surgery procedures is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Do 2-stage bariatric surgery procedures improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is 2-stage bariatric surgery. Bariatric surgeries performed in 2 stages have been proposed as a treatment option, particularly for patients with “super-obesity” defined as a BMI greater than 50 kg/m². The rationale for a 2-stage procedure is that the risk of an extensive surgery is prohibitive in patients who are extremely obese. Therefore, a procedure with low-risk (usually an SG) is performed first. After the patient loses some weight, thus lowering the surgical risk, a second more extensive procedure (e.g., BPD) is performed.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating 2-stage bariatric surgery as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 5 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 1 to 5 years of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trial
Coffin et al. (2017) published results on the use of intragastric balloon (IGB) prior to a laparoscopic gastric bypass in patients with super-obesity.⁸⁶ Patients with a BMI greater than 45 kg/m² were randomized to an IGB (n = 55) or standard medical care (n = 60) during the 6 months prior to a planned laparoscopic gastric bypass procedure. Five patients had the IGB removed earlier than 6 months due to complications (n = 3) or patient request (n = 2). Patients receiving IGBs during the first 6 months of the study experienced significantly more BMI reduction (2.8 kg/m²; range 1.7 to 6.2 kg/m²) than patients receiving standard care (0.4 kg/m²; range 0.3 to 2.2 kg/m²). Weight loss during months 6 through 12, after the laparoscopic gastric bypass procedure, was greater in the patients who received standard of care before the procedure. Duration of hospitalization after laparoscopic gastric bypass and quality of life did not differ between groups.

Case Series
Most of the evidence on 2-stage procedures consists of case series of patients undergoing SG as the initial procedure. Many do not report on the second-stage surgery. A minority of patients undergoing first-stage surgery proceed to second-stage surgery. Cottam et al. (2006) reported on 126 patients with a mean BMI of 65 kg/m² who underwent LSG as the first phase of a planned 2-stage procedure.⁸⁷ The incidence of major perioperative complications for LSG was 13%. After 1 year, mean EWL was 46%. Thirty-six (29%) patients proceeded to the second-stage procedure, which was laparoscopic gastric bypass. The incidence of major complications following the second procedure was 8%.

In a similar study, Alexandrou et al. (2012) reported on 41 patients who underwent SG as the first-stage of a planned 2-stage procedure.⁸⁸ After 1-year of follow-up, 12 (29%) patients achieved a BMI of less than 35 kg/m² and were ineligible for the second-stage procedure. Of the remaining 28 patients, 10 (24%) underwent the second-stage procedure. The remaining 18 (44%) patients were eligible for but had not undergone, the second-stage procedure at the last follow-up.

Patients who undergo 2-stage procedures are at risk for complications from both procedures. Silecchia et al. (2009) described the complication rates in 87 patients who underwent a stage 1 SG followed by BPD in 27 patients.⁸⁹, For the first stage, 16.5% of patients had complications of bleeding, fistula, pulmonary embolism, acute renal failure, and abdominal abscess. For the 27 patients who underwent the second-stage BPD, 29.6% had major complications, including bleeding, duodeno-ileal stenosis, and rhabdomyolysis.

Section Summary: Two-Stage Bariatric Surgery Procedures for Adults With Morbid Obesity
The evidence from an RCT and several case series does not support a 2-stage bariatric surgery procedure for improving outcomes in patients with extreme levels of obesity. There is no evidence to suggest that weight loss is improved or that complications are reduced by this approach. Most patients who receive SG as the initial procedure lose sufficient weight during the first year so that a second procedure is no longer indicated. Also, patients undergoing a 2-stage procedure are at risk for complications from both procedures; therefore, it is likely that overall complications are increased by this approach.

Laparoscopic Gastric Plication for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of laparoscopic gastric plication is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does laparoscopic gastric plication improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is laparoscopic gastric plication. Laparoscopic gastric plication is a bariatric procedure that involves laparoscopic placement of sutures over the greater curvature (laparoscopic greater curvature plication) or anterior gastric region (laparoscopic anterior curvature plication) to create a tube-like stomach. To achieve gastric restriction the procedure requires 2 main steps, mobilization of the greater curvature of the stomach and suture plication of the stomach.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating laparoscopic gastric plication as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 12 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up of 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Li et al. (2021) reported on a systematic review of 18 studies (N = 1,329) comparing outcomes after laparoscopic SG versus laparoscopic greater curvature gastric plication.⁹⁰ Results demonstrated that SG is superior to greater curvature gastric plication with regard to providing effective weight loss through 24 months; statistical significance was not reached at 36 months. The difference in the improvement of comorbidities such as T2D, hypertension, and OSA did not reach statistical significance between groups, nor did the risks of major complications or mortality.

Ji et al. (2014) reported on a systematic review of 14 studies reporting outcomes after laparoscopic gastric plication.⁹¹ Reviewers included a nonrandomized matched cohort analysis, 10 uncontrolled case series, and 3 case reports. The nonrandomized cohort study was small (N = 19). Only 3 studies identified included more than 100 patients. Mean preoperative BMI ranged from 31.2 to 44.5 kg/m². Mean percent EWL after the procedure was reported in 9 studies (n = 1,407 patients), and ranged from 31.8% to 74.4% at follow-up times ranging from 6 to 24 months. One study reported weight loss in terms of percent decrease in BMI, with a reported decrease at 6 and 12 months of 66.4% and 60.2%, respectively. One study compared anterior plication with greater curvature plication and reported increased weight loss with greater curvature plication (percent EWL, 53.7% versus 23.3%, respectively). Reporting of complications was heterogeneous across studies, but no deaths were reported, and the rate of major postoperative complications requiring reoperation ranged from 0% to 15.4% (average, 3.7%), most commonly due to gastric obstruction or gastric perforation. Surgical techniques were not standardized.

In a systematic review, Abdelbaki et al. (2012) summarized outcomes from 7 studies of laparoscopic gastric plication, 2 of which enrolled more than 100 patients (N = 307 patients).⁹² All studies reported some incidence of nausea and vomiting, most of which were mild. Twenty (6.5%) patients were readmitted, of whom 14 (4.6%) patients required reoperation, most commonly for gastric obstruction (8/14 [57%]). Table 8 provides a comparison of the studies included in these systematic reviews. Tables 9 and 10 discuss characteristics and results, respectively.

Table 8. Comparison of Trials/Studies Included in SR & M-A

Study	Li et al. (2021)	Ji et al. (2014)	Abdelbaki et al. (2021)
Abdelbaki et al. (2014)	⚫
Abdelnazer et al. (2016)	⚫
Abouzeid et al. (2015)	⚫
Atlas et al. (2013)		⚫
Brethauer et al. (2011)		⚫	⚫
Buzga et al. (2017)	⚫
Casajoana et al. (2017)	⚫
Chouillard et al. (2015)	⚫
Fried et al. (2012)		⚫
Grubnik et al. (2015)	⚫
Hi et al. (2012)		⚫
Li et al. (2018)	⚫
Lopeznava et al. (2020)	⚫
Morshed et al. (2011)	⚫
Miu et al. (2013)		⚫
Nabil et al. (2018)	⚫
Neagoe et al. (2019)	⚫
Niazi et al. (2013)		⚫
Park et al. (2017)	⚫
Pujol Gebelli et al. (2011)		⚫	⚫
Ramos et al. (2010)		⚫	⚫
Sharma et al. (2014)	⚫
Skrekas et al. (2011)		⚫	⚫
Shen et al. (2013)	⚫	⚫
Taha et al. (2012)		⚫
Talebpour et al. (2007)			⚫
Talebpour et al. (2017)	⚫	⚫
Toprak et al. (2015)	⚫
Tsang et al. (2012)		⚫	⚫
Verdi et al. (2015)	⚫
Watkins et al. (2012)		⚫	⚫

M-A: meta-analysis; SR: systematic review. 

Table 9. Systematic Review Characteristics for Laparoscopic Gastric Plication

Study	Dates	Studies	Participants	Design	Duration
Li et al. (2021)90	Dec 2020	18	1,329	6 retrospective cohort; 7 prospective cohort; 5 RCTs	1 mo to 3 y
Ji et al. (2014)91	Jun 2013	14	1,450	1 matched cohort; 10 case series; 3 case reports	6 mo to 10 y
Abdelbaki et al. (2012)92	NR	7	307	5 case series; 2 case reports	3 y

NR: not reported; RCT: randomized controlled trial.

Table 10. Systematic Review Results for Laparoscopic Gastric Plication

Study	% Excessive Weight Loss	Complications	Conclusions
Li et al. (2021)90	MD (95% CI) between SG and gastric plication: 6 mo: 5.37 (1.59 to 9.16) 12 mo: 13.23 (9.93 to 16.54) 24 mo: 19.62 (1.15 to 38.08) 36 mo: 24.63 (-1.94 to 51.21)	OR (95% CI) between SG and gastric plication: Bleeding: 1.37 (0.61 to 3.09) Stenosis: 0.57 (0.23 to 1.38) Leak: 1.58 (0.61 to 4.15) Mortality: 1.39 (0.09 to 22.55)	SG is superior to gastric plication with regard to providing effective weight loss in the short- and mid-term. The procedures are similar in terms of major complications.
		Rate % (range)
Ji et al. (2014)91	31.8 to 74.4	3.7 (0 to 15.4)	Favorable short-term efficacy and safety profile; long-term follow-up and prospective trials needed
Abdelbaki et al. (2012)92	6 mo: 51 to 54 12 mo: 53 to 67	8 (7 to 15.3)	Prospective randomized trials vs. gastric plication with established bariatric procedures needed

CI: confidence interval; MD: mean difference; OR: odds ratio; SG: sleeve gastrectomy.

Randomized Controlled Trials
In additional to the studies included in the above-summarized systematic reviews, Sullivan et al. (2017) published results from the randomized, subject and evaluator-blinded, parallel-group, multicenter clinical trial using an endoscopic suturing device (G-CATH EZ™ suture anchor delivery catheter) for primary weight loss (ESSENTIAL), a randomized sham-controlled trial evaluating the efficacy and safety of endoscopic gastric plication (Table 11).⁹³ Patients (N = 332) were randomized 2:1 to the active or sham procedure. All patients were provided low-intensity lifestyle therapy (LT). The primary endpoint was total body weight loss (TBWL) at 12-month follow-up. The MD in TBWL for patients receiving the procedure compared with patients receiving the sham procedure was 3.6% (95% CI, 2.1 to 5.1). Significant differences between the active and sham groups were also reported in a change in weight from baseline, percent excess weight loss, BMI, and improvement in diabetes (Table 12). No significant differences were detected in improvements in hyperlipidemia or hypertension between the treatment groups.

Table 11. RCT Characteristics for Laparoscopic Gastric Plication

					Interventions
Interventions	Countries	Sites	Dates	Participants	Active	Comparator
Sullivan et al. (2017)93	U.S.	11	2013 – 2014	Patients 22 to 60 y, BMI ≥ 30 kg/m2, and ≥ 1 obesity-related comorbidity, or BMI ≥ 35 kg/m2, and with or without obesity-related comorbidity Race (active, sham): White: 71%, 64.8% Indian: 0%, 0.9% Black: 28.1%, 31.5% Mixed: 0.9%, 2.8% Ethnicity (active, sham) Not Hispanic/Latino: 93.7%, 92.8% Hispanic/Latino: 6.3%, 7.2%	Endoscopic gastric plication (n = 221)	Sham procedure (n = 111)

BMI: body mass index; RCT: randomized controlled trial.

Table 12. RCT Results for Laparoscopic Gastric Plication

Study; Trial Name	BMI Reduction	Weight Lossa
	Mean Change (SD)b	Difference (95% CI)	Mean (SD)b	Difference (95% CI)
Sullivan et al. (2017);93 ESSENTIAL		1.2 (0.6 to 1.9)		3.6 (2.1 to 5.1)
Endoscopic gastric plication	1.7		4.9 (7.0)
Sham	0.5		1.4 (5.6)

BMI: body mass index; CI: confidence interval; ESSENTIAL: The randomized, subject and evaluator-blinded, parallel-group, multicenter clinical trial using an endoscopic suturing device (G-CATH EZ™ suture anchor delivery catheter) for primary weight loss; RCT: randomized controlled trial; SD: standard deviation.
^a For Sullivan et al. (2017), percent total body weight loss at 12 months. 
^b At 12-month follow-up.

Study relevance, design, and conduct limitations are summarized in Tables 13 and 14.

Table 13. Study Relevance Limitations

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Duration of Follow-upe
Sullivan et al. (2017);93 ESSENTIAL	4. Majority White, not Hispanic/Latino patients.	4. Low-intensity lifestyle therapy used with procedure.	2. Low-intensity lifestyle therapy used.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. 
^a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 14. Study Design and Conduct Limitations

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Sullivan et al. (2017);93 ESSENTIAL	5. Lead-in cohort of 34 subjects was not randomized but underwent the active treatment procedure for the purposes of investigator training.	1. Evaluator-blinded only.			4. Weight loss results were lower in both the active and sham control groups than estimated in the power analysis.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.
^b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other.
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Observational Study
Pattanshetti et al. (2013) published the results of a study that described the evolution of an LAGB plication procedure, a hybrid procedure involving both LAGB and greater curvature plication developed by the authors.⁹⁴ Eighty patients were included, with a baseline mean BMI of 38.05 kg/m2. At 6, 12, 18 and 24 months postsurgery, mean percent EWL was 42.6%, 56.4%, 57.6% and 65.8%, respectively. Five postoperative complications required reoperation.

Section Summary: Laparoscopic Gastric Plication for Adults with Morbid Obesity
There is a shortage of comparative studies, especially RCTs, comparing the safety and efficacy of laparoscopic gastric plication with other bariatric surgery procedures. A 2021 systematic review demonstrated that SG is superior to greater curvature gastric plication with regard to providing effective weight loss through 24 months; statistical significance was not reached at 36 months. The difference in the improvement of comorbidities and risk of major complications or mortality did not reach statistical significance between groups. One RCT compared endoscopic gastric plication with a sham procedure, reporting 1-year follow-up results in favor of the intervention. Longer-term follow-up and additional comparative studies are needed.

Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy for Adults with Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does SADI-S improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is SADI-S.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating SADI-S as a treatment for morbid obesity has varying lengths of follow-up, ranging from 3 to 5 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
No controlled trials of SADI-S were identified. Some case series have reported on weight loss and other clinical outcomes up to 5 years postsurgery.

Systematic Review
In 2018, Shoar et al. published a systematic review of 12 studies, comprising 5 cohorts, 4 case series, and 3 case reports, that reviewed the efficacy and safety of SADI-S.⁹⁵ The studies included 581 patients who underwent SADI-S. These patients were between 18 and 71 years of age with a BMI between 33 to 71.5 kg/m2. Of the total surgeries, 508 (87.4%) were primary and 73 (12.6%) were revisional. Follow-up was available between 6 and 60 months after the procedure. Results revealed the average percent EWL was 30% at 3 months, 55% at 6 months, 70% at 1 year, and 85% at 2 years. The comorbidity resolution rate was 74.1% for T2D, 96.3% for hypertension, 68.3% for dyslipidemia, 63.3% for OSA, and 87.5% for GERD. The most common complication was diarrhea (1.2%) and vitamin A, selenium, and iron deficiency were the most common nutritional deficiencies. There was also the possibility of protein malnutrition in up to 34% of patients when measured. The authors concluded that SADI-S was associated with a promising short-term weight loss outcome and comorbidity resolution rate; however, RCTs are warranted to compare this procedure to more commonly performed bariatric procedures.

Observational Studies
Torres et al. (2017) published a retrospective chart review of patients from their center receiving bariatric procedures, evaluating outcomes at 3-year follow-up.⁹⁶ Outcomes were evaluated separately for patients with and without diabetes. For patients without diabetes, comparisons were made among patients who underwent RYGB (n = 149) or SADI-S (n = 106). For patients with diabetes, comparisons were made among patients who underwent RYGB (n = 97), BPD-DS (n = 77), or SADI-S (n = 97). Among the patients without diabetes, significant differences favoring SADI-S over RYGB were found in: percent EWL; systolic blood pressure; total, high-density lipoprotein and low-density lipoprotein cholesterol; and insulin. Significant differences were not found in diastolic blood pressure or fasting glucose. Among the patients with T2D, remission rates using American Diabetic Association criteria were: 55%, 70%, and 76% for patients receiving RYGB, BPD-DS and SADI-S, respectively. Patients with diabetes who underwent BPD-DS or SADI-S achieved significantly lower total cholesterol and triglyceride levels compared with those undergoing RYGB after 3 years of follow-up.

Case Series
One larger series, by Sanchez-Pernaute et al. (2015), reported on 97 patients with obesity and T2D.⁹⁷ The authors reported that control of diabetes, defined as HbA1C levels less than 6.0%, was achieved by between 70% and 84% of patients at different time points. Remission rates were higher for patients on oral therapy than those on insulin and were higher in patients with a shorter duration of diabetes.

Section Summary: Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy for Adults With Morbid Obesity
A systematic review of 12 observational studies concluded that SADI-S was associated with promising weight loss and comorbidity resolution. No published controlled trials have evaluated SADI-S. A comparative chart review found that patients without diabetes experienced significantly better weight loss and lipid profiles with SADI-S than with RYGB and patients who had diabetes experienced significantly higher rates of remission with SADI-S than with RYGB. Long-term safety and efficacy outcomes and comparative RCTs are still needed.

Duodenojejunal Sleeve for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of the duodenojejunal sleeve procedure is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does the duodenojejunal sleeve procedure improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is the duodenojejunal sleeve procedure.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating duodenojejunal sleeve as a treatment for morbid obesity has varying lengths of follow-up, ranging from 3 to 6 months. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Review
The EndoBarrier (GI Dynamics) is a fluoropolymer sleeve that is reversibly fixated to the duodenal bulb and extends 80 cm into the small bowel, usually terminating in the proximal jejunum. A systematic review of the effect of EndoBarrier on weight loss and diabetes control outcomes was published in 2016.98, It included 5 small RCTs (N = 235 patients; range, 18 to 77 patients), with follow-up ranging from 12 to 24 weeks. Comparators were diet and/or other lifestyle modifications, and 2 studies had sham controls. All studies were judged to be at high-risk of bias using the Cochrane risk of bias tool. Combined results demonstrated that the EndoBarrier group had 12.6% greater EWL (95% CI, 9.0 to 16.2) than medical therapy. For diabetes control outcomes, trends toward greater improvement in the EndoBarrier group were not statistically significant. MD in HbA1C level was -0.8% (95% CI, -1.8 to 0.3) and the RR of reducing or discontinuing diabetic medications was 3.28 (95% CI, 0.54 to 10.73).

Randomized Controlled Trial
The largest single trial was a multicenter RCT published in 2014; it included 77 patients with T2D and a BMI greater than 30 kg/m2.99, Patients were treated for 6 months with EndoBarrier or medical therapy. At 6 months, the EndoBarrier was removed, and patients were followed for an additional 6 months. Thirty-eight patients were randomized to the EndoBarrier group, and 31 (82%) of 38 completed 12 months of treatment. Thirty-nine patients were randomized to medical treatment, and 35 (90%) of 39 completed 12 months of treatment. At 6 months, the decrease in BMI was significantly greater in the EndoBarrier group than in the medical therapy group (3.3 kg/m2 versus 1.8 kg/m², p < .05), and at 12 months the difference in BMI was of marginal statistical significance (2.2 kg/m² versus 1.3 kg/m², p = .06), respectively. HbA1C level was significantly lower in the EndoBarrier group at 6 months (7.0% versus 7.9%, p < .05), but at 12 months the difference between groups did not differ significantly (7.3% versus 8.0%, p = .95).

Observational Study
Obermayer et al. (2021) evaluated outcomes after treatment with EndoBarrier in 10 patients with T2D and an average BMI of 43.3 kg/m2.¹⁰⁰ Results demonstrated that EndoBarrier reduced mean body weight from 121.2 ± 18.5 kg to 116.3 ± 18.2 kg (p = .006) 4 weeks after the start of therapy, and to 115.1 ± 21.4 kg (p = .075 vs. baseline) until explantation of the device after 36 weeks. There was an increase in weight to 117.2 ± 20.8 kg (p = 0.117 vs. baseline) 24 weeks after explanation.

Section Summary: Duodenojejunal Sleeve for Adults With Morbid Obesity
A systematic review of evidence on a duodenojejunal sleeve included 5 RCTs and found significantly greater short-term weight loss (12 to 24 weeks) with duodenojejunal sleeves compared with medical therapy. There was no significant difference in symptom reduction associated with diabetes. However, all RCTs had small sample sizes and were judged by the systematic reviewers to be at high-risk of bias.

Intragastric Balloon Devices for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of IGB devices is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Do IGB devices improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is IGB devices. IGB devices are placed in the stomach via endoscope or swallowing to act as space-occupying devices to induce satiety. As of 2017, 2 IGB devices have U.S. Food and Drug Administration (FDA) approval, each designed to stay in the stomach for no more than 6 months. Obalon is a swallowable 3-balloon system. The OBERA Intragastric Balloon System (previously marketed outside of the United States as BioEnterics) is a saline-inflated silicone single balloon system.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating IGB devices as a treatment for morbid obesity has varying lengths of follow-up, ranging from 5 to 10 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up of 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Several systematic reviews of RCTs evaluating IGB devices for the treatment of obesity have been published; none was limited to FDA-approved devices.^{101,102,103,104}

Kotinda et al. (2020) published a systematic review and meta-analysis that evaluated the efficacy of IGB devices in comparison to sham or lifestyle interventions in overweight and obese adults.¹⁰⁴ Thirteen RCTs with 1523 patients were included. Results revealed that the mean percent EWL difference between the IGB and control groups was 17.98% (95% CI, 8.37 to 27.58; p < .00001), significantly favoring IGB. IGB was also significantly favored when evaluating the mean percent TWL difference between the groups: 4.40% (95% CI, 1.37 to 7.43; p < .00001). Similarly, the difference in actual weight loss and BMI loss was 6.12 kg and 2.13 kg/m², respectively. Overall, IGB was found to be more effective than lifestyle intervention alone for weight loss; however, the majority of included RCTs used 1 fluid-filled IGB and there was significant heterogeneity between the included studies.

The systematic review by Tate et al. (2017) focused on RCTs, published between 2006 and 2016.¹⁰⁵ Additional inclusion criteria were: sham, lifestyle modification, or pharmacologic agent as a comparator; at least 1 outcome of body weight change; and study duration of 3 or more months. Eight RCTs were included in the review, with 4 contributing to the meta-analysis. The meta-analysis included 777 patients and showed a significant improvement in percent TBWL with IGB compared with control (5.5%; 95% CI, 4.3 to 6.8). However, there was significant heterogeneity among the trials (I2 = 62%), so interpretation of results is limited. The percent TBWL with IGB is lower than expected with RYGB (reported 27%) or with the most efficacious pharmacologic agent (reported 9%).

Saber et al. (2017) identified 20 RCTs reporting weight loss outcomes after IGB implantation or a non-IGB control intervention.¹⁰¹ IGB was compared with sham in 15 trials, behavioral modification in 4 trials, and pharmacotherapy in 1 trial. In 17 trials, patients received LT in addition to other interventions. Studies were published between 1987 and 2015 and sample sizes varied from 21 to 326 participants. Outcomes were reported between 3 and 6 months. In a meta-analysis of 7 RCTs reporting BMI loss as an outcome, there was a significantly greater BMI loss in the IGB group than in the control group (mean effect size [ES], 1.59 kg/m2; 95% CI, -0.84 to 4.03; p < .001). Findings on other outcomes were similar. A meta-analysis of 4 studies reporting percent EWL favored the IGB group (ES = 14.25%; 95% CI, 2.09 to 26.4; p = .02). Also, a meta-analysis of 6 studies reporting absolute weight loss favored the IGB group (ES = 4.6 kg; 95% CI, 1.6 to 7.6; p = .003).

Although the review was not limited to FDA approved devices, older devices were air-filled and newer devices, including the 2 approved by FDA in 2015, are fluid-filled. Sufficient data were available to conduct a sensitivity analysis of 3-month efficacy data. A meta-analysis of 4 studies did not find a significant difference in weight loss with air-filled IGB devices or a control intervention at 3 months (ES = 0.26; 95% CI, -0.12 to 0.64; p = .19). In contrast, a meta-analysis of 8 studies of fluid-filled devices found significantly better outcomes with the IGB than with control (ES = 0.25; 95% CI, 0.05 to 045; p = .02).

Randomized Controlled Trials
Pivotal trials on FDA-approved devices have been published.

Courcoulas et al. (2017) published a multicenter, pivotal RCT evaluating the Obera IGB in the United States (as noted, the device has been used in other countries).¹⁰⁶ A total of 317 patients were randomized and initiated 6 months of treatment with an IGB plus LT (n = 137) or LT only (n = 136). Patients were followed for an additional 6 months. Key eligibility criteria were age 18 to 65 years, baseline BMI between 30 and 40 kg/m2, a history of obesity for at least 2 years, and having failed previous weight loss attempts. Nineteen patients in the IGB group and 121 in the control group completed the 6-month treatment period.

Coprimary effectiveness outcomes, assessed at 9 months, were mean percent EWL and difference in mean weight loss. Mean percent EWL at 9 months was 26.4% in the IGB group and 10.1% in the control group (difference, 16.2%; 95% CI, 12.3 to 20.2; p < .001). Mean weight loss at 9 months was -8.8 kg (-19.4 lb) in the IGB group and -3.2 kg (-7.1 lb) in the control group (p < .001). There were also significant between-group differences in mean weight loss and mean percent EWL at 6 and 12 months.

Most adverse events in the Obera pivotal trial were anticipated accommodative symptoms. A total of 139 (87%) patients reported nausea, 121 (76%) reported vomiting, and 92 (58%) reported abdominal pain. Fewer than 5% of these adverse events were serious; most were mild or moderate. Thirty patients in the device group had the IGB removed before month 6 because of an adverse event (n = 15) or patient request (n = 15). There were no deaths and 9 serious adverse events unrelated to device accommodation; among others, these included a case of gastric outlet obstruction and a case of gastric perforation with sepsis.

The Courcoulas et al. (2017) pivotal trial was not blinded or sham-controlled; however, a double-blind sham-controlled randomized trial evaluating the BioEnterics IGB (now called the Obera device) was published by Genco et al. (2006).¹⁰⁷ This crossover trial included 32 obese patients ages 25 to 50 years with a mean BMI of 47.3 kg/m². Patients received, in random order, 3 months of an IGB and 3 months of sham. (Both groups underwent upper gastrointestinal endoscopy, but no device was placed in the sham group.) Patients who initially received the IGB had a mean BMI reduction of 5.8 kg/m² after 3 months; after crossover to sham, these patients had a mean additional BMI reduction of 1.1 kg/m². Patients initially in the sham group had an initial mean BMI reduction of 0.4 kg/m2; after crossover to an active device, these patients had a mean BMI reduction of 5.1 kg/m². The between-group difference in BMI reductions was statistically significant (p < .001). Findings on other outcomes (mean percent EWL, mean weight loss) were similar.

Case Series
A case series of patients treated with an IGB with up to 60-month follow-up was published by Kotzampassi et al. (2012),¹⁰⁸ A total of 500 patients were treated with the BioEnterics IGB. Twenty-six patients did not complete the initial 6 months of treatment, and another 77 patients did not comply with dietary restrictions and did not have satisfactory weight loss at 6 months. Among 352 patients with data available, BMI was 44.5 kg/m² at baseline, 35.7 kg/m² at device removal, 38.8 kg/m² 12 months after device removal, and 40.1 kg/m² 24 months after device removal. Mean percent EWL was 43.9% at device removal, 27.7% 12 months after device removal, and 17% 24 months after device removal. Among the 195 patients with available 5-year data, mean baseline BMI was 43.3 kg/m², mean BMI at device removal was 33.8 kg/m², and mean BMI at 5 years was 40.1 kg/m². Mean percent EWL at 5 years was 13.0%. Overall, patients who initially complied with 6 months of IGB device use and lost weight slowly gained weight over time but weighed less at final follow-up than at baseline.

Section Summary: Intragastric Balloon Devices for Adults With Morbid Obesity
Evidence includes RCTs, a case series with long-term follow-up on 1 of the devices, and systematic reviews on various IGB devices. RCTs have found significantly better weight loss outcomes with IGB devices compared with sham treatment or LT alone. One RCT followed patients for an additional 6 months after IGB removal and found sustained weight loss. A large case series with follow-up up to 5 years has suggested that patients regain weight over time. Additional long-term follow-up data are needed. There are some adverse events, and in a minority of cases, these adverse events can be severe. The FDA wrote 2 letters in 2017 to health care providers, 1 warning of spontaneous balloon inflation and pancreatitis and the other reporting 5 unanticipated deaths occurring in 2016 to 2017 following the IGB procedure. In June 2018, the FDA reported that, since 2016, a total of 12 deaths occurred in patients with liquid-filled intragastric balloons worldwide; 7 of these deaths were in patients in the U.S. Health care providers are encouraged to monitor patients receiving IGBs.

Aspiration Therapy Device for Adults With Morbid Obesity
Clinical Context and Therapy Purpose
The purpose of the aspiration therapy (AT) device is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity.

The question addressed in this evidence review is: Does the AT device improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity.

Interventions
The therapy being considered is the AT device.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating AT device as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 2 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 1 to 2 years of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trials
AT involves an FDA-approved device (AspireAssist) that allows patients to drain a portion of the stomach contents after meals via an implanted tube connected to an external skin port. One RCT has been published. The Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) trial, by Thompson et al. (2017), randomized 207 participants to 52 weeks of AspireAssist therapy plus lifestyle counseling (n = 127) or lifestyle counseling alone (n = 70).¹⁰⁹ Participants were between 21 and 65 years of age, with a BMI ranging from 35 to 55 kg/m². Coprimary outcomes were mean EWL at 52 weeks and the proportion of patients with 25% or more EWL at 52 weeks. Investigators did a modified intention-to-treat analysis including all patients in the AspireAssist group who attempted tube placement (n = 111) and all patients in the lifestyle counseling group who attended at least 1 therapy session (n = 60). Mean EWL at 52 weeks was 31.5% in the AspireAssist group and 9.8% in the lifestyle counseling group. The difference between groups was 21.7% (95% CI, 15.3 to 28.1), which was greater than the 10% difference needed to meet the a priori definition of success. The proportion of patients with 25% or more EWL at 52 weeks was 58.6% in the AspireAssist group and 22% in the lifestyle counseling group (p < .001). Bulimia or binge eating disorder were exclusion criteria and, during the study, there was no evidence that patients developed bulimia or that devices were overused (i.e., used > 3 times a day). Most of the adverse events (83.8%) in the AspireAssist group were associated with placement of a percutaneous endoscopic gastric tube. All 5 serious adverse events occurred in the AspireAssist group (mild peritonitis, severe abdominal pain and a case of product malfunction). Product malfunction was related to malfunction of the A-tube, typically occurring within the first week of implantation and seen in 90% of adverse events seen with the AspireAssist. The durability of a treatment effect beyond 1 year was not reported.

Thompson et al. (2019) published 4-year outcomes from the PATHWAY trial.¹¹⁰ AT patients were permitted to continue the study beyond 1 year up to a maximum of 5 years provided they maintained at least 10% TWL from baseline at each year end. Out of 82 AT patients who completed year 1, 58 continued in the next phase, 43 completed year 2, 22 completed year 3, and 15 completed year 4 in the trial. Of 58 AT participants continuing in the study, 43 withdrew before completion of year 4, with 25/43 meeting their weight loss goal or losing > 10% of their baseline weight. Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Out of 60 patients treated in the LT control group, only 31 completed the full initial study year. Two serious adverse events were reported in years 2 to 4. One patient developed a secondary fistula superior to the A-tube fistula, which resolved following A-tube removal. The second patient experienced an A-tube malfunction, which was replaced. A total of 57 adverse events, including the 2 serious adverse events, were recorded. The adverse events with the greatest frequency were peristomal irritation (12 events), persistent fistulas (12 events), and peristomal granulation tissue (8 events). A total of 27 A-tubes required replacement over the 4 years of the study. Reasons for replacement include tube defects (~ 50%) and tube leaks (~ 30%). According to the study survival analysis, one can expect 50% of A-tubes to be replaced within approximately 3.5 years postgastrostomy. No clinically significant metabolic disorders were observed. No evidence for the development of any eating disorders was noted. Study results are summarized in Table 15. Study relevance, design and conduct limitations are summarized in Tables 16 and 17.

Table 15. Results of PATHWAY Trial

		> 25% EWL1	% TWL	ΔHbA1C2	IW Quality of Life Total Score2,3
Thompson et al. (2017); PATHWAY109	Year 1, n	% [95% CI]	% (SD) [95% CI]	% (SD)	Mean (SD)
AT	mITT: 111 PP: 82	mITT: 56.8 [49.0 to 64.5] PP: 68.3 [NR]	mITT: 12.1 (9.6) [NR] PP: 14.2 (9.8) [12.1 to 16.4]	mITT: -0.36 (0.45) PP: NR	mITT: 6.2 (13.4) PP: NR
LT	mITT: 60 PP: 31	mITT: 22.0 [15.3 to 28.1] PP: 25.8 [NR]	mITT: 3.6 (6.0) [NR] PP: 4.9 (7.0) [NR]	mITT: -0.22 (0.27) PP: NR	mITT: 3.3 (10.0) PP: NR
Mean Difference [95% CI]		NR	8.6 [6.2 to 10.9]2	-1.4 [-0.28 to 0.0]2	2.9 (SD: 12.5)2
P-Value		mITT: < .001 PP: < .001	NR	P = .052	P = .034
Thompson et al. (2019); PATHWAY110	AT5	> 25% EWL1		% TWL
		% (SD)		% (SD) [95% CI]
Year 1	82	68.3 (NR)		14.2 (9.8) [12.1 to 16.4]
Year 2	43	72.1 (NR)		15.3 (8.8) [12.6 to 18.0]
Year 3	22	63.6 (NR)		16.6 (10.5) [12.0 to 21.3]
Year 4	15	73.3 (NR)		18.7 (11.7) [12.2 to 25.2]

AT: aspiration therapy; CI: confidence interval; EWL: excess weight loss; HbA1c: hemoglobin A1c; IWquality of life: Impact of Weight of Quality of Life survey; LT: lifestyle therapy; mITT: modified intent-to-treat; NR: not reported; PATHWAY: 
Pivotal Aspiration Therapy with Adjusted Lifestyle; PP: per protocol; SD: standard deviation; TWL: total weight loss. 
¹ Primary outcome measure. 
² Based on the modified intent-to-treat analysis. 
³ Improvement in quality-of-life measures is reflected by increasing IWquality of life scores. 
⁴ Treatment differences in individual IWquality of life component scores did not reach statistical significance.
⁵ Based on the per-protocol analysis.

Table 16. Study Relevance

Study; Trial	Populationa	Interventionb	Comparatorc	Outcomesd	Follow-Upe
Thompson et al. (2017; 2019); PATHWAY109,110	4. The majority of enrolled patients were white, non-Hispanic.		2: No active comparator for years 2 to 4.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
PATHWAY: Pivotal Aspiration Therapy with Adjusted Lifestyle.
^a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4. Enrolled populations do not reflect relevant diversity; 5. Other.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 17. Study Design and Conduct Limitations

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Thompson et al. (2019); PATHWAY109,110		2: Blinding to outcome assessment unclear. 3: Blinding and identity of outcome assessors unclear.		1: High loss to follow-up or missing data. High loss to pre- and post-enrollment withdrawals. 2: Multiple strategies utilized for handling of missing data. 5: Inappropriate exclusion of patients with TWL < 10% during years 2 – 4 from analysis. 6: Modified intent to treat analysis not carried through.	1: Study not powered beyond 1 y of follow-up. Study underpowered for completers at 1 y. 3: Rationale for clinically important difference not provided.	2: Not all sensitivity analyses are statistically significant for primary effectiveness outcome (at least 50% of participants achieving at least 25% EWL); unclear if analysis is appropriate for multiple observations per patient or extent of missing data.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
EWL: excess weight loss; PATHWAY: Pivotal Aspiration Therapy with Adjusted Lifestyle; TWL: total weight loss.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. No intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Case Series
In addition to the RCT, a case series by Noren and Forssell (2016) evaluated AspireAssist use by 25 obese patients.¹¹¹ Patients had 1 year of AT and also participated in a cognitive-behavioral therapy weight loss program for the initial 3 months. Patients were instructed to aspirate 3 times a day after meals. Twenty (80%) patients completed the 1-year intervention period. Mean baseline weight was 107.4 kg. In a per-protocol analysis, the mean EWL was 54.5% at 12 months. Data on 15 (60%) patients were available at 24 months; mean EWL was 61.5%.

Section Summary: Aspiration Therapy Device for Adults With Morbid Obesity
The evidence consists of an RCT with 4 years of follow-up and a small case series with up to 2 years of follow-up. The RCT found significantly greater weight loss (measured several ways) with AT compared with LT at 1 year. Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal; however, only 15/111 initial AT patients completed the study through 4 years. In addition to a high degree of missing data, the PATHWAY study noted a potentially high degree of adverse events related to A-tube malfunction, an element of the therapy which is expected to require replacement within approximately 3.5 years postgastrostomy in 50% of cases. The impact of this on health outcomes compared to existing surgical approaches is unknown. The case series followed only 15 patients more than 1 year; at 2 years, study completers had not regained weight and instead had lost additional excess weight. The total amount of data on AT remains limited and additional studies need to be conducted before conclusions can be drawn about the long-term effects of treatment on weight loss, metabolism, safety and nutrition.

Revision Bariatric Surgery for Adults With Morbid Obesity Who Failed Bariatric Surgery
Clinical Context and Therapy Purpose
The purpose of revision bariatric surgery is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adults with morbid obesity and who failed bariatric surgery

The question addressed in this evidence review is: Does revision bariatric surgery improve the net health outcome in adults who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adults with morbid obesity and failed bariatric surgery.

Interventions
The therapy being considered is revision bariatric surgery.

Comparators
Comparators of interest include standard medical care. Treatment for adults with morbid obesity includes physical exercise, low carbohydrate dieting, and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating revision bariatric surgery as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 3 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up of 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Matar et al. (2021) published a systematic review of 556 patients (n = 17 studies) who underwent RYGB for SG-related complications, including GERD (30.4% cases) and insufficient weight loss and weight regain (52% of cases).¹¹² The mean BMI at the time of conversion ranged from 33.3 to 48.3 kg/m². The pooled baseline BMI at conversion was 38.5 kg/m² (95% CI, 36.49 to 40.6), at 6 months was down to 28.6 kg/m² (95% CI, 16.1 to 41.0), and after 1 year was up to 32.1 kg/m² (95% CI, 25.50 to 38.7). The pooled mean %TWL after completion of treatment was 25.2% (95% CI, 12.8 to 37.5) at 6 months and 22.8% (95% CI, 13.5 to 32.1) at 1 year. There was a 16.4% complication rate at 30 days, which decreased to 11.4% after 30 days. At 1-year post RYGB, the rate of resolution for common comorbidities was as follows: GERD, 79.7% (95% CI, 59.6 to 91.3); T2D, 57.7% (95% CI, 36.9 to 76.1); hypertension, 49.4% (95% CI, 25.8 to 73.3).

Parmar et al. (2020) published a systematic review of 1,075 patients (n = 17 studies) who underwent one anastomosis/mini gastric bypass (OABG-MGB) as a revisional bariatric procedure after failure of a primary LAGB and SG.¹¹³ No RCTs were available on this topic and no meta-analyses were performed as part of this systematic review. The most commonly reported reason for revisional surgery was poor response (81%) followed by gastric band failure (35.9%), GERD (13.9%), intolerance (12.8%), staple line disruption (16.5%), pouch dilatation (17.9%), and stomal stenosis (10.3%). Results revealed that after the revisional OABG-MGB, the mean percent EWL was 50.8% at 6 months, 65.2% at 1 year, 68.5% at 2 years, and 71.6% at 5 years. Resolution of comorbidities after OAGB-MGB was significant with 80.5% of patients with T2D, 63.7% of patients with hypertension, and 79.4% of patients with GERD reporting resolution. The overall readmission rate following OAGB-MGB was 4.73%, the mortality rate was 0.3%, and the leak rate was 1.54%. Although the authors concluded that OAGB-MGB is a safe and effective choice for revisional bariatric surgery, RCTs on this topic are needed as currently only retrospective cohort studies with heterogenous data are available.

Brethauer et al. (2014) conducted a systematic review of reoperations after primary bariatric surgery for the American Society for Metabolic and Bariatric Surgery that included 175 studies, most of which were single-center retrospective reviews.¹¹⁴ The review is primarily descriptive, but made the following conclusions:

“The current evidence regarding reoperative bariatric surgery includes a diverse group of patient populations and procedures. The majority of the studies are single institution case series reporting short- and medium-term outcomes after reoperative procedures. The reported outcomes after reoperative bariatric surgery are generally favorable and demonstrate that additional weight loss and co-morbidity reduction is achieved with additional therapy. The risks of reoperative bariatric surgery are higher than with primary bariatric surgery and the evidence highlights the need for careful patient selection and surgeon expertise.”

Nonrandomized Studies
Petrucciani et al. (2021) published a retrospective analysis of 215 patients who underwent revisional OAGB with a biliopancreatic limb of 150 cm after failing LAGB at a single center between 2010 and 2016.¹¹⁵ The indication for surgery was weight loss failure in 30.7% of cases and long-term complications in the remaining cases. The mean BMI at the time of OAGB was 42 kg/m². At 2 years after OAGB, 9.7% of patients were lost to follow-up, BMI was down to 28 ± 5.5 kg/m², %EWL was 88.2 ± 23.9, and %TWL was 38.7 ± 9.3. At 5 years after OAGB, 16.6% of patients were lost to follow-up, BMI was slightly up to 29.2 ± 5.8 kg/m², %EWL was 82.4 ± 25, and %TWL was 36.1 ± 10. Overall postoperative morbidity was 13.5% with a 5.9% rate of postoperative abscess with or without staple line leak. Treatment-resistant GERD occurred in 21.3% of patients; conversion to RYGB was required in 4.2% of cases.

Almalki et al. (2018) published a retrospective analysis of patients diagnosed with failed restrictive procedure who underwent revision bariatric surgery.¹¹⁶ One hundred sixteen patients between 2001 and 2015 had revision RY gastric bypass (R-RYGB; n = 35) or revision single anastomosis- (mini-) gastric bypass (R-SAGB; n = 81); the primary indications for revisional procedures were weight regain (50.9%), inadequate weight loss (31%), and intolerance (18.1%). Major complications occurred in 12 (10%) patients without significant difference between groups (R-SAGB, n = 9; R-RYGB, n = 3). At 1 year after revision surgery, the R-SAGB group (76.8% EWL) showed better weight loss than R-RYGB (32.9% EWL; p = .001). In the 37.1% of patients available for follow-up at 5 years, R-SAGB had significantly lower hemoglobin levels than R-RYGB (8.2 ± 3.2 g/dl versus 12.8 ± 0.5 g/dl; p = .03). The study was limited by its retrospective nature, relatively short follow-up time, and lack of consideration of data related to patient compliance.

Sudan et al. (2015) reported on safety and efficacy outcomes for reoperative bariatric surgeries using data from a national registry, the Bariatric Outcomes Longitudinal Database.117, The Bariatric Outcomes Longitudinal Database was a large, multi-institutional bariatric surgery-specific database to which data were submitted from 2007 through 2012 by 1029 surgeons and 709 hospitals participating in the Bariatric Surgery Centers of Excellence program. Surgeries were classified as primary or reoperative bariatric. Reoperations were further divided into corrective surgeries (when complications or incomplete treatment effect of a previous bariatric operation was addressed, but the initial operation was not changed) or conversions (when an index bariatric operation was changed to a different type of bariatric operation or a reversal restored original anatomy.) Of 449,473 bariatric operations in the database, 420,753 (93.6%) operations had no further reoperations (primary operations) while 28,270 (6.3%) underwent reoperations. Of the reoperations, 19,970 (69.5%) were corrective and 8,750 (30.5%) were conversions. The primary bariatric operations were RYGB (n = 204,705 [49.1%]), LAGB (n = 153,142 [36.5%]), SG (n = 42,178 [10%]), and BPD-DS (n = 4,260 [1%]), with the rest classified as miscellaneous. LAGB was the most common primary surgery among conversions (57.5% of conversions; most often [63.5%] to RYGB). Compared with primary operations, mean hospital length of stay was longer for corrections (2.04 days versus 1.8 days, p < .001) and for conversions (2.86 days versus 1.8 days, p < .001). Mean percent EWL at 1 year was 43.5% after primary operation, 39.3% after conversions, and 35.9% after corrective operations (statistical comparison not reported). One-year mortality was higher for conversions (0.31%) than for primary surgeries (0.17%; p < .001), with no statistically significant difference for corrections (0.24%) compared with primary surgeries (0.17%; p = NS). One-year serious adverse event rates were higher for conversions (3.61%) than for primary operations (1.87%; p < .001), with no statistically significant difference for corrections (1.9%) compared with primary operations (1.87%; p = NS). The authors concluded that reoperation after primary bariatric surgery is relatively uncommon, but generally safe and efficacious when it occurs.

Endoscopic Revision Procedures
While bariatric surgery revision or correction can be conducted using standard surgical approaches, novel endoscopic procedures are being developed. Some procedures use devices also being evaluated for the endoscopic treatment of GERD (see evidence review 2.01.38). The published data on the use of these devices for treatment of regained weight is limited. Published case series have reported results using a number of devices and procedures (including sclerosing injections) as a treatment for this condition. The largest series (2007) found involved 28 patients treated with a sclerosing agent (sodium morrhuate).¹¹⁸ Reported trials that used 1 of the suturing devices had fewer than 10 patients. For example, Herron et al. (2008) reported on a feasibility study in animals.¹¹⁹ Thompson et al. (2006) reported on a pilot study with changes in anastomotic diameter and weight loss in 8 patients who regained weight and had dilated gastrojejunal anastomoses after RYGB.¹²⁰ No comparative trials were identified; comparative trials are important because of the known association between an intervention and short-term weight loss.

The StomaphyX device, which has been used in this approach, was cleared by FDA through the 510(k) process. It was determined to be equivalent to the EndoCinch system, which has 510(k) marketing clearance for endoscopic suturing for gastrointestinal tract surgery. Eid et al. (2014) reported on results from a single-center RCT that compared the StomaphyX device with a sham procedure for revisions in patients with prior weight loss after RYGB at least 2 years earlier.¹²¹ Enrollment was initially planned for 120 patients, but the trial was stopped prematurely after 1-year follow-up was completed by 45 patients in the StomaphyX group and 29 patients in the sham control group because preliminary analysis failed to achieve the primary efficacy endpoint in at least 50% of StomaphyX patients. The primary 12-month efficacy endpoint (reduction in pre-RYGB excess weight by ≥ 15%, excess BMI loss, and BMI < 35 kg/m²) was achieved by 10 (22.2%) of 45 in the StomaphyX group and 1 (3.4%) of 29 in the sham control group (p < .01).

A 2009 survey of American Society for Metabolic and Bariatric Surgery members (bariatric surgeons) indicated different risk tolerance and weight loss expectations for primary and revisional endoscopic procedures.⁶³ The surgeons were “willing to accept less weight loss and more risk for revisional endoluminal procedures than for primary endoluminal procedures.” The durability of the procedures was a concern, and most surgeons were unwilling to consider the procedures until their efficacy has been proven. A 2013 systematic review of studies reporting outcomes after endoluminal revision of primary bariatric surgery conducted by the American Society for Metabolic and Bariatric Surgery concluded: “The literature review shows the procedures on the whole to be well tolerated with limited efficacy. The majority of the literature is limited to small case series. Most of the reviewed devices are no longer commercially available."¹²²

Cohen et al. (2019) conducted a systematic review evaluating the safety and efficacy of endoscopic gastroplasty for medically uncontrolled obesity.¹²³ Nine observational studies and a single RCT were identified by the authors. Follow-up duration in the majority of studies was limited to 6 to 12 months with several studies reporting high rates of loss to follow-up. Percent total body weight loss ranged from -15.1% to 19.5%. Reduction in BMI ranged from -1.69 to -7.5 kg/m². Serious adverse events ranged from 2% to 10%. The quality of the current evidence was graded very low to moderate, with limited long-term data on weight loss durability and procedure safety.

Section Summary: Revision Bariatric Surgery for Adults With Morbid Obesity Who Failed Bariatric Surgery
For surgical revision of bariatric surgery after failed treatment, evidence from systematic reviews and nonrandomized studies suggests that revisions are associated with improvements in weight similar to those seen in primary surgery. However, the published scientific literature on the use of endoscopic devices and procedures in patients who regain weight after bariatric surgery is very limited.

Bariatric Surgery as a Treatment for Type 2 Diabetes for Adults With Diabetes Who Are Not Morbidly Obese
Clinical Context and Therapy Purpose
The purpose of gastric bypass, SG, BPD, and adjustable gastric banding is to provide treatment options that are alternatives to or improvements on existing therapies, such as standard medical care, in patients who are diabetic and not morbidly obese.

The question addressed in this evidence review is: Do various bariatric surgery procedures improve the net health outcome in those with diabetes who are not obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are diabetic and not morbidly obese.

Interventions
The therapy being considered is gastric bypass, SG, BPD, and adjustable gastric banding. Current indications for bariatric surgery view poorly or uncontrolled diabetes as a comorbidity whose presence supports the need for surgery in patients with a BMI of 35 to 40 kg/m². There also is growing interest in gastrointestinal surgery to treat patients with T2D in patients with lower BMI.

Comparators
Comparators of interest include standard medical care. Treatment for patients who are diabetic includes blood sugar regulation and insulin therapy.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating gastric bypass, SG, BPD, and adjustable gastric banding as a treatment for diabetes has varying lengths of follow-up, ranging from 1 to 5 years.

While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

This section focuses on RCTs and systematic reviews of RCTs comparing bariatric surgery with medical therapy.

Review of Evidence
Type 2 Diabetes and Body Mass Index 30 to 34.9 kg/m²
Systematic Reviews
Wu et al. (2016) published a meta-analysis of studies comparing bariatric surgery with nonsurgical interventions for patients who had T2D.¹²⁴ Eight RCTs with 619 patients were included. RCTs addressed RYGB (6 studies), LAGB (3 studies), LSG (1 study), and BPD (1 study). Mean BMI across studies was 29 kg/m² or higher; in 6 of 8 studies, mean BMI was 35 kg/m² or higher. One study had a 5-year follow-up, and the others had 1 to 3 years of follow-up. The study with a 5-year follow-up, by Mingrone et al. (2015), was limited to patients with a BMI of at least 35 kg/m².¹²⁵ All 8 studies reported remission of T2D as an efficacy endpoint. A pooled analysis found a significantly higher rate of T2D remission in the bariatric surgery versus the nonsurgical treatment group (RR, 5.76; 95% CI, 3.15 to 10.55; p < .001). Another diabetes-related outcome (mean reduction in HbA1C levels) was significantly greater after bariatric surgery than nonsurgical treatment (MD, -1.29; 95% CI, -1.70 to -0.87). Also, there was a significantly greater reduction in BMI with bariatric surgery than with nonsurgical treatment (MD, -5.80; 95% CI, -6.95 to -4.64; p < .001).

Since the publication of the Wu et al. (2016) meta-analysis, 5-year follow-up has been reported for the Schauer et al. (2017) RCT, which is shown in Table 18. When the Wu et al. (2016) meta-analysis was published, only 3-year findings of the Schauer etal (2017) study were available. The study included patients with T2D who had a BMI of 27 to 43 kg/m². The RCTs evaluating bariatric surgery in patients with T2D, including the 5-year follow-up of the Schauer et al. (2017) study, are summarized in Table 18.

Muller-Stich et al. (2015) published a systematic review of RCTs and observational studies on bariatric surgery in patients with T2D and a BMI less than 35 kg/m².¹²⁶ Eleven comparative trials of medical therapy versus bariatric surgery were included, with 5 RCTs and 6 nonrandomized comparative studies identified. Follow-up was between 1 and 3 years. The primary outcome reported was remission of diabetes. On combined analysis, bariatric surgery was associated with a higher remission rate than medical therapy (OR, 14.1; 95% CI, 6.7 to 29.9; p < .001). On secondary outcomes, surgery was associated with a greater decrease in BMI (MD, -5.5 kg/m2; 95% CI, -6.7 to -4.3; p < .001), a lower HbA1C level (MD, -1.4%; 95% CI, -1.9 to -0.9; p < .001), lower rates of hypertension (OR, 0.25; 95% CI, 0.12 to 0.50; p < .001), and lower rates of dyslipidemia (OR, 0.21; 95% CI, 0.10 to 0.44; p < .001).

Also, Rao et al. (2015) published a meta-analysis of short-term outcomes for patients with T2D and a BMI of 35 kg/m² or less who underwent RYGB.¹²⁷ Nine articles were included (N = 343 patients). After 12 months, patients with T2D had a significant decrease in BMI (weighted MD, -7.42; 95% CI, -8.87 to -5.97; p < .001) and improvements in HbA1C levels (weighted MD, -2.76; 95% CI, -3.41 to -2.11; p < .000). Reviewers reported that longer term follow-up would be needed.

Previously, a 2012 TEC Assessment evaluated bariatric surgery in diabetic patients with a BMI less than 35 kg/m².¹²⁸ The evidence consisted mainly of case series. The Assessment identified only observational studies. Based on the data, the Assessment concluded that gastric bypass met TEC criteria as a treatment for diabetes in patients with a BMI less than 35 kg/m² but that other procedures did not meet the TEC criteria for this indication:

• There were no randomized trials comparing bariatric surgery with medical treatment for diabetic subjects with a BMI less than 35 kg/m². There was only 1 randomized trial comparing 2 bariatric procedures. Therefore, studies were categorized by procedure type and presented as case series, regardless of the underlying study type.
• Nine studies reported diabetes remission rates and other outcomes in subjects undergoing gastric bypass. Diabetes remission rates varied between 48% and 100% at follow-up times of 1 year and beyond. One study was a randomized trial of gastric bypass versus SG; in it, diabetes remission associated with gastric bypass was 93% versus 47% for SG at 1 year.
• Two studies reported outcomes of SG. Diabetes remission rates were 55% and 47% at 1 year.
• One study reported outcomes of ileal interposition. The diabetes remission rate at a mean follow-up time of 39.1 months was 78.3%.
• Two studies reported outcomes of gastric banding. The outcomes reported were not considered to be rigorous, because the only measure of diabetes outcome was the withdrawal of diabetes medication. Reported remission rates were 27.5% and 50% at variable follow-up times.
• One study of BPD reported a remission rate of 67% for subjects with a BMI between 30 and 35 kg/m² and 27% for subjects with a BMI between 25 and 30 kg/m² at 12-month follow-up.
• One study reported outcomes of duodenojejunal exclusion. Subjects in this study had more severe diabetes than subjects enrolled in other studies; 100% were on insulin treatment, and the duration of diabetes was between 5 and 15 years. The diabetes remission rate was 17% at 6 months.

Summaries of various systematic reviews and meta-analyses on the use of bariatric or metabolic surgery in patients with a BMI < 35 kg/m² are available, and report efficacy in achieving weight loss, glycemic control, T2D remission, and mitigation of various cardiovascular disease factors through 1 to 5 years of follow-up.^129,130 However, current studies are limited by heterogeneity in applied surgical intervention and threshold definitions for T2D remission. Longer-term (> 5 years) RCTs evaluating the use of metabolic surgery in lower BMI patients for the treatment of T2D are pending (NCT02328599).

Observational studies evaluating patients undergoing bariatric surgery in patients with T2D with a follow-up to 3 or more years are shown in Table 18.

Table 18. Randomized Controlled Trials of Bariatric Surgery Procedures Comparing Patients Who Had Type 2 Diabetes With Controls

Study (Country)	N	BMI Range, kg/m2	Patients With BMI ≤35 kg/m2	Length of FU, years	Definition of Diabetes Remission	Diabetes Remission Rate, n/N (%)			P-Value
Simonson et al. (2019)131 (U.S.)	40	30 to 45	39% LAGB; 36% DWM	3	FBS < 126 mg/dL AND HbA1C < 6.5%	13%		5%	.601
						Surgery (LAGB)		Control (ILI/A1C-R)
Dixon et al. (2008)49 (U.S.)	60	30 to 40	22%	2	% achieving FBS < 126mg/dL HbA1C < 6.2% (off meds)	22/30 (93%)		4/30 (13%)	< .001
						Surgery (RYGB)		Control (HILI/A1C-R)
Ikramuddin et al. (2015)132 (U.S.)	120	30 to 40	59%	2	% achieving all 3 ADA goals: HbA1C < 7.0% LDL < 2.59 mmol/L SBP < 130 mm Hg	26/60 (43%)		8/59 (14%)	< .001
						Surgery (RYGB)	Control 1 (GCP/A1C-R)	Control 2 (GCP/A1C-S)
Liang et al. (2013)133 (China)	108	>28g		1	T2D remissionb	28/31 (90%)	0%	0%	< .05
						Surgery (RYGB)	Surgery (LAGB)	Control (HILI/A1C-S)
Courcoulas et al. (2015)134 (U.S.)	61	30 to 40	43%	3	Partial: HbA1C < 6.5% Full: HbA1C < 5.7% (off meds)	8/20 (40%) Full: 3/20 (15%)	6/21 (29%) Full: 1/21 (5%)	0%	.004
Courcoluas et al. (2020)135, (U.S.)				5	Partial: HbA1c < 6.5% Full: HbA1C < 5.7% (off meds)	6/20 (30%) Full: 1/20 (5%)	4/21 (19%) Full: 0	0%	.0208
						Completers
						Surgery (RYGB)	Surgery (LSG)	Control (ILI/A1C-S)
Schauer et al. (2017)136, (U.S.)	150	27 to 43	37%	5h	% HbA1C < 6.0% (meds)	14/49 (29%)	11/49 (23%)	2/38 (5%)	0.01c/0.03d
						Intention-to-Treat
						26.4%	20.4%	7.3%	0.08e/0.17f
						Surgery (RYGB)	Surgery (BPD)	Control (GCP/A1C-S)
Mingrone et al. (2015)125, (Italy)	60	35+	0%	5	%HbA1C ≤ 6.5% (% meds × 1 y)	8/19 (42%)	13/19 (68%)	0%	< 0.001
						Surgery (LAGB)		Control (ILI/A1C-R)
Wentworth et al. (2014)137, (Australia)	51	25 to 30	100%	2	< 125 mg/dL or 200 mg/dL 2-h OGTT (off meds x 2 d)	12/23 (52%)		2/25 (8%)	0.001
						Surgery (RYGB)		Control (HILI/A1C-S)
Halperin et al. (2014)138, (U.S.)	43	30 to 42	30%	1	% HbA1C < 6.5%	11/19 (58%)		3/19 (16%)	.03

ADA: American Diabetes Association; A1C-R: HbA1c reasonable goal of < 7%; A1C-S: HbA1c stringent goal of < 6.5%; BMI: body mass index; BPD: biliopancreatic diversion; DWM: diabetes and weight management; FBS: fasting blood sugar; FU: follow-up; GCP: good clinical practice; HbA1c: hemoglobin A1c; HILI: 
highly intensive lifestyle intervention; ILI: intensive lifestyle intervention; LAGB; laparoscopic adjustable gastric banding; 
LDL: low-density lipoprotein; LSG: laparoscopic sleeve gastrectomy; OGTT: Oral Glucose Tolerance Test; RYGB: Roux-en-Y gastric bypass; SBP: systolic blood pressure; T2D: type 2 diabetes.
^a All RCTs in this table are in the Wu et al. (2016) meta-analysis; 7 of the 8 (except Mingrone et al) are in the Muller-Stich et al. (2015) meta-analysis; the Rao et al. (2015) meta-analysis and the TEC Assessment did not include RCTs. 
No additional RCTs comparing bariatric surgery with nonsurgical treatment in patients who had T2D were identified.
^b Used as a secondary outcome. Primary outcome was change in left ventricular mass index.
^c Unadjusted (RYGB vs. control).
^d Unadjusted (LSG vs. control).
^e RYGB vs. control.
^f LSG vs. control.
^g WHO Asia-Pacific Obesity Classification.
^h Through February 2017.

Table 19. Observational Studies Assessing Bariatric Surgery in Patients With Type 2 Diabetes With Follow-Up ≥3 Years

Study (Country)	N	BMI Range, kg/m2	Patients With BMI ≤35 kg/m2	Length of FU	Interv	Mean HbA1c	Mean BMI, kg/m2	Diabetes Remission Rate
Group 1						Base	FU	Base	FU
Scopinaro et al. (2014)80 (Italy)	20 treated; 27 matched diabetic controls	30 to 34.9	100%	3 y	RYGB	9.5%	7.0%a	32.9	26.0a	5/20 (25%)
					Control	9.3%	7.7%a	33.0	32.6
Lanzarini et al. (2013)139 (Chile)	31	30 to 35	100%	30 moc	RYGB	7.9%	5.5%a	33.1	24.7a	29/31 (94%)
Boza et al. (2011)140 (Chile)	30	< 35	100%	2 y	RYGB	8.1%	≈6.2%a,b	33.5	23.9a	12 mo: 25/30 (83.3%) 2 y: 13/20 (65%)
DePaula et al. (2012)141 (Brazil)	202	< 35	100%	39 moc	SG	8.7%	6.1%a	29.7	23.5a	171/198 (86.4%)
Group 2
Lee et al. (2008)35 and142 (Taiwan)	544 bypass	32 to 77	NR	3 y	Bypass	6.2%	4.8%	41.3	28.0	NR
	116 LAGB		NR		LAGB	5.9%	5.2%	41.9	32.7	NR

Group 1 is defined as poor control optimal medical management (may include insulin). Group 2 is defined as adequate control with medication (may include insulin).
Base: baseline; BMI: body mass index; Bypass: mini-gastric bypass; FU: follow-up; HbA1c: hemoglobin A1c; Interv: intervention; LAGB; laparoscopic adjustable gastric banding; NR: not reported; RYGB: Roux-en-Y gastric bypass; SG: sleeve gastrectomy.
^a p < .05 (follow-up vs baseline).
^b Estimated from figure.
^c Mean.

Section Summary: Bariatric Surgery as a Treatment for Type 2 Diabetes for Adults with Diabetes Who Are Not Morbidly Obese
Systematic reviews of RCTs and observational studies have found that certain types of bariatric surgery are more efficacious than medical therapy as a treatment for T2D in obese patients, including those with a BMI between 30 and 34.9 kg/m². The greatest amount of evidence assesses gastric bypass, with some comparative studies on LAGB, LSG, and BPD. Systematic reviews have found significantly greater remission rates of diabetes, decrease in HbA1c levels, and decrease in BMI with bariatric surgery than with nonsurgical treatment. The efficacy of surgery is balanced against the short-term risks of the surgical procedure. Most RCTs in this population have 1 to 5 years of follow-up data.

Bariatric Surgery in Nondiabetic Patients With a Body Mass Index Less Than 35 kg/m²
Clinical Context and Therapy Purpose
The purpose of any bariatric surgery procedure is to provide a treatment option that is an alternative to or improvement on existing therapies, such as standard medical care, in patients who are not diabetic and not morbidly obese.

The question addressed in this evidence review is: Do various bariatric surgery procedures improve the net health outcome in those without diabetes who are not obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are not diabetic and not morbidly obese.

Interventions
The therapy being considered is any bariatric surgery procedure.

Comparators
Comparators of interest include standard medical care. Treatment for patients who are diabetic includes blood sugar regulation and insulin therapy.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating any bariatric surgery procedure as a treatment for diabetes has varying lengths of follow-up, ranging from 1 to 3 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
A 2012 TEC Assessment evaluated LAGB in individuals without diabetes who had a BMI less than 35 kg/m².¹⁴³, This assessment was prompted by FDA approval of LAP-BAND for this indication in 2011. The TEC Assessment concluded that LAGB did not meet TEC criteria in these patients and made the following summary statements:

The evidence on LAGB for patients with lower BMIs is limited both in quantity and quality. There was only 1 small RCT, which had methodologic limitations, a nonrandomized comparative study based on registry data, and several case series. Using the GRADE evaluation, the quality of evidence on the comorbidity outcomes was judged to be low, and the quality of the evidence on the weight loss outcomes was judged to be moderate.

The evidence was sufficient to determine that weight loss following LAGB was greater than with nonsurgical therapy.

Direct data on improvement in weight-related comorbidities was lacking. The limited evidence was not sufficient to conclude that the amount of weight loss is large enough that improvements in weight-related comorbidities could be assumed.

There were very few data on quality of life in this population of patients.

The frequency and impact of long-term complications following LAGB were uncertain, and this uncertainty has been 1 of the main reasons why it is difficult to determine whether the benefit of LAGB outweighs the risk for this population. While the short-term safety of LAGB has been well-established, the long-term adverse events occur at a higher rate and are less well-defined.

Section Summary: Bariatric Surgery in Nondiabetic Patients With a Body Mass Index Less Than 35 kg/m²
There is limited evidence for bariatric surgery in patients who are not diabetic or morbidly obese. A few small RCTs and case series have reported a loss of weight and improvements in comorbidities for this population. However, the evidence does not permit conclusions on the long-term risk-benefit ratio of bariatric surgery in this population.

Bariatric Surgery in Morbidly Obese Adolescent Children
Clinical Context and Therapy Purpose
The purpose of gastric bypass, LAGB, or SG is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are adolescent children with morbid obesity.

The question addressed in this evidence review is: Do various bariatric surgery procedures improve the net health outcome in adolescents who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are adolescent children with morbid obesity. While guidelines for bariatric surgery in adolescents are not uniform, most use weight-based criteria that parallel those for adults.

Interventions
The therapy being considered is gastric bypass, LAGB or SG.

Comparators
Comparators of interest include standard medical care. Treatment for adolescent children with morbid obesity includes physical exercise, low carbohydrate dieting and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating gastric bypass, LAGB, or SG as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 6 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Bariatric Surgery Techniques
Review of Evidence
Systematic Reviews
Qi et al. (2017) published a systematic review and meta-analysis on the use of bariatric surgery for the treatment of adolescents with obesity (Table 20).¹⁴⁴ In a literature search conducted through July 2017, 49 studies were identified for inclusion. Study quality was assessed using the Newcastle-Ottawa Scale. Age of patients ranged from 14 to 20 years. BMI ranged from 34 to 63 kg/m². Overall results showed significant improvements in BMI as well as glycemic and lipid control with various bariatric surgery techniques. RYGP showed the largest improvements compared with other procedures, with LAGB and SG also showing improvements in this population.

In a systematic review of 23 studies, Black et al. (2013) concluded that the available literature demonstrated a high rate of significant short-term weight loss after bariatric surgery (Table 21).¹⁴⁵ The literature search was conducted through January 2013. Quality assessment of the included studies was not discussed. Ages of patients at the time of surgery ranged from 5 to 23 years. A meta-analysis showed significant reductions in BMI. Meta-analyses were not conducted on the resolution of comorbidities due to heterogeneity in reporting. However, most cases of hypertension, OSA, T2D, and dyslipidemia were reported to have resolved at 1-year follow-up. Reviewers noted that complication and comorbidity rates were not well-defined.

Treadwell et al. (2008) conducted a systematic review and meta-analysis of the published evidence on bariatric surgery in adolescents (Table 21).¹⁴⁶ Their analysis included English-language articles on currently performed procedures when data were separated by procedure, and there was a minimum 1-year follow-up for weight and BMI. Studies must have reported outcomes data for 3 or more patients ages 21 years or younger, representing at least 50% of pediatric patients enrolled at that center. Nineteen studies reported on between 11 and 68 patients who were 21 years or younger. Eight studies of LAGB (mean BMI, 45.8 kg/m²; median age range, 15.6 to 20 years); 6 studies on RYGB (mean BMI, 51.8 kg/m²; median age range, 16 to 17.6 years); 5 studies of other procedures (mean BMI, 48.8 kg/m²; median age range, 15.7 to 21 years) were included.

Meta-analyses of BMI at longest follow-up indicated sustained and clinically significant reductions for both LAGB and RYGB (Table 21). Comorbidity resolution was sparsely reported, but surgery appeared to resolve some medical conditions, including diabetes and hypertension; 2 studies of LAGB showed large rates of diabetes resolution but low patient enrollment, and only 1 study of RYGB reported relevant data. No in-hospital or postoperative deaths were reported in any LAGB study. The most frequently reported complications for LAGB were band slippage and micronutrient deficiency with sporadic cases of band erosion, port/tube dysfunction, hiatal hernia, wound infection, and pouch dilation. More severe complications were reported for RYGB, such as pulmonary embolism, shock, intestinal obstruction, postoperative bleeding, staple line leak, and severe malnutrition. No in-hospital deaths were reported; however, 1 patient died 9 months after the study with severe Clostridium difficile colitis; 3 others died of causes not likely to have been directly related to the bariatric surgeries. No LAGB studies reported data on the impact of surgery on growth and development. One study of RYGB reported pre- and postoperative heights and concluded that there was no evidence of growth retardation at an average follow-up of 6 years, but it could not be determined from the data whether expected growth was achieved.

Table 20. Systematic Review Characteristics for Bariatric Surgery for Adolescents With Obesity

Study	Dates	Studies	Participants	Design	Duration
Qi et al. (2017)144	Jul 2017	49	RYGP: 1216 LAGB: 1028 LSG: 665 Other: 98	1 RCT 22 prospective 26 retrospective	12 to 120 mo
Black et al. (2013)145	Jan 2013	23	RYGP: 256 LAGB: 271 LSG: 90 Other: 20	1 controlled 22 uncontrolled	6 to 120 mo
Treadwell et al. (2008)146	Dec 2007	18	RYGB: 131 LAGB: 352 Other: 158	1 prospective 17 retrospective	0 to 22 y

LAGB: laparoscopic adjustable gastric banding; LSG: laparoscopic sleeve gastrectomy; RCT: randomized controlled trial; RYGP: Roux-en-Y gastric bypass.

Table 21. Systematic Review Results for Bariatric Surgery for Adolescents With Obesity

Study	BMI Reduction Mean Difference (95% CI)	Fasting Blood Insulin, mlU/L Mean Difference (95% CI)	Total Cholesterol, mg/dL Mean Difference (95% CI)
Qi et al. (2017)144
RYGP	18.5 (16.4 to 20.7)	24.8 (10.0 to 30.7)	29.4 (18.1 to 40.7)
LAGB	12.1 (11.0 to 13.3)	20.5 (16.4 to 24.6)	2.2 (-10.0 to 14.4)
LSG	16.0 (13.2 to 20.7)	18.4 (11.4 to 25.3)	13.6 (2.9 to 24.2)
Other	23.2 (15.6 to 30.7)	28.3 (5.7 to 50.9)	49.5 (29.9 to 69.2)
Black et al. (2013)145
RYGP	17.2 (14.3 to 20.1)	NR	NR
LAGB	10.5 (9.1 to 11.8)	NR	NR
LSG	14.5 (11.7 to 17.3)	NR	NR
Other	NR	NR	NR
Treadwell et al. (2008)146
RYGP	(17.8 to 22.3)a	NR	NR
LAGB	(10.6 to 13.7)a

BMI: body mass index; CI: confidence interval; LAGB: laparoscopic adjustable gastric banding; LSG: laparoscopic sleeve gastrectomy; NR: not reported; RYGP: Roux-en-Y gastric bypass;
^a No point estimate provided, only 95% CIs given.

Observational Studies
Dumont et al. (2018) published a retrospective study of obese adolescents who underwent LAGB.¹⁴⁷ Between 2006 and 2015, 97 consecutive teenagers (average age at surgery 17.2 ± 0.7 years; mean BMI of 44.9 ± 6.1 kg/m²) who had achieved full growth and sexual maturity and had previously failed a medical nutritional and dietary management program for at least 1 year were enrolled in the study. After a mean follow-up time of 56.0 ± 22.0 months, mean total weight loss was 20.0 ± 16.6% and mean excess weight loss was 46.6 ± 39.5%. Nineteen patients underwent band removal (mean 43.0 ± 28.0 months). No limitations to the study were reported.

One of the larger observational studies included in the systematic reviews was by Inge et al. (2014), who reported results from the Teen-Longitudinal Assessment of Bariatric Surgery study, a prospective, multicenter observational study of bariatric surgery in patients ages 19 or younger.¹⁴⁸ The study enrolled 242 patients, with a mean age of 17.1 years and median BMI of 50.5 kg/m² (IQR, 45.2 to 58.2 kg/m²) at the time of surgery. All patients had at least 1 obesity-related comorbidity, most commonly dyslipidemia (74%), followed by OSA (57%), back and joint pain (46%), hypertension (45%), and fatty liver disease (37%). Gastric bypass, LAGB, and vertical SG were performed in 66.5%, 5.8%, and 27.7% of patients, respectively. Within 30 days of surgery, 20 major complications occurred in 19 (7.9%) patients, most of which were perioperative. The cohort is being followed to assess longer term outcomes.

Gastric Bypass
Comparative Studies
Olbers et al. (2017) published results from the Adolescent Morbid Obesity Surgery (AMOS) study.¹⁴⁹ AMOS is a prospective, nonrandomized study of patients ages 13 to 18 years with severe obesity. Enrolled patients underwent RYGB (n = 81) and were compared with 80 matched adolescent controls undergoing conservative treatment and 81 matched adult controls undergoing RYGB. The primary outcome was change in BMI after 5 years. Adolescents undergoing RYGB had a mean age of 16.5 years and mean BMI of 45.5 kg/m² At 5-year follow-up, adolescents receiving RYGB experienced a mean reduction in BMI of 13.1 kg/m² (95% CI, 11.8 to 14.5). Adolescents receiving conservative treatment experienced a mean increase in BMI of 3.3 kg/m2 (95% CI, 1.1 to 4.8). Adult controls receiving RYGB experienced a reduction in BMI similar to the adolescents undergoing RYGB, 12.3 kg/m2 (95% CI, 10.9 to 13.7). Adolescents undergoing RYGB also experienced significant improvements in glucose, insulin, cholesterol and blood pressure levels compared with adolescents in the control group.

Laparoscopic Adjustable Gastric Banding
Systematic Reviews
Willcox and Brennan (2014) conducted a systematic review focusing on studies reporting biopsychosocial outcomes following LAGB in adolescents with obesity.¹⁵⁰ The literature search, conducted through May 2013, identified 11 studies for inclusion. Significant weight loss was reported in all studies. Resolution of comorbidities was also reported, though the evidence was poor quality due to a limited discussion of comorbidity assessment criteria. Reporting of psychosocial outcomes was considered limited, with reviewers concluding that further research is needed to better understand the behavioral, emotional, and social factors experienced by adolescents undergoing LAGB.

Randomized Controlled Trials
In the only RCT identified in the systematic reviews, O’Brien et al. (2010) reported on 50 adolescents between the ages of 14 and 18 years with a BMI 35 kg/m² or higher who received either a lifestyle intervention or LAGB.¹ Follow-up was 2 years. Twenty-four of 25 patients in the gastric banding group and 18 of 25 in the lifestyle group completed the study. Twenty-one (84%) in the gastric banding group and 3 (12%) in the lifestyle group lost more than 50% of excess weight. Overall, mean weight loss in the gastric banding group was 34.6 kg (95% CI, 30.2 to 39.0), representing an EWL of 78.8% (95% CI, 66.6 to 91.0). Mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1 to 8.1), representing an EWL of 13.2% (95% CI, 2.6 to 21.0). The gastric banding group experienced improved quality of life with no perioperative adverse events; however, 8 (33%) surgeries were required in 7 patients for revisional procedures, either for proximal pouch dilatation or tubing injury during follow-up.

Case Series
There are many case series of bariatric surgery in adolescents, and these series have generally reported weight loss in the same range reported for adults. For example, Nadler et al. (2008) reported on 73 patients ages 13 to 17 years who had undergone LAGB since 2001 at the authors’ institution.¹⁵¹ Mean preoperative BMI was 48 kg/m2. EWL at 6 months, 1 year, and 2 years postoperatively was 35%, 57%, and 61%, respectively. Six patients developed band slippage, and 3 developed symptomatic hiatal hernias. Nutritional complications included an asymptomatic iron deficiency in 13 patients, asymptomatic vitamin D deficiency in 4 patients, and mild subjective hair loss in 14. In the 21 patients who entered the authors’ FDA-approved study and had reached 1-year follow-up, 51 comorbid conditions were identified, 35 of which completely resolved, 9 were improved, 5 were unchanged, and 2 were aggravated after 1 year.

Sleeve Gastrectomy
Manco et al. (2017) published results from contemporaneous cohorts of adolescent patients with a BMI of 35 kg/m² or more and nonalcoholic steatohepatitis who chose between 3 treatment options.¹⁵², Twenty patients chose to undergo LSG, 20 patients opted to ingest intragastric weight-loss devices (IGWLD, either the BioEnterics Intragastric Balloon System or Obalon Gastric Balloon) plus lifestyle interventions, and 53 patients chose lifestyle interventions alone. All patients in the LSG and IGWLD groups completed the study; 22 of the 53 in the lifestyle intervention group completed the study. After 1-year follow-up: patients undergoing LSG lost 21% body weight; patients treated with IGWLD lost 3% body weight, and patients receiving lifestyle interventions only gained 2% body weight. Nonalcoholic steatohepatitis reverted in 100% of patients receiving LSG and in 24% receiving IGWLD. Patients receiving lifestyle interventions alone did not improve significantly.

Section Summary: Bariatric Surgery in Morbidly Obese Adolescent Children
Gastric Bypass, Laparoscopic Adjustable Gastric Banding or Sleeve Gastrectomy
Several systematic reviews and meta-analyses have been conducted on observational studies evaluating the use of bariatric surgery for the treatment of adolescents with obesity. There is an overlap of studies among the systematic reviews. The majority of evidence assesses the use of gastric bypass, SG, or LAGB. Two nonrandomized comparative studies were published after the systematic reviews. One compared RYGB with conservative treatment and with adults undergoing RYGB, and 1 compared LSG with gastric balloons and lifestyle interventions. The evidence on bariatric surgery in adolescents indicates that the percent EWL and change in BMI are approximately the same as that in adults. There are greater concerns for developmental maturity, psychosocial status and informed consent in adolescents.

Bariatric Surgery Other Than Gastric Bypass, Laparoscopic Adjustable Gastric Banding or Sleeve Gastrectomy
There is less evidence for the use of bariatric techniques other than gastric bypass, LAGB, and SG. Sample sizes are small for these other techniques and meta-analyses have shown wide CIs in the estimates.

Guideline recommendations for bariatric surgery in adolescents lack uniformity but generally correspond to the clinical selection criteria for adults and supplement these clinical selection criteria with greater attention to issues of maturity and psychosocial status.

Bariatric Surgery in Morbidly Obese Preadolescent Children
Clinical Context and Therapy Purpose
The purpose of bariatric surgery is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients who are preadolescent children with morbid obesity.

The question addressed in this evidence review is: Do various bariatric surgery procedures improve the net health outcome in preadolescents who are obese?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are preadolescent children with morbid obesity.

Interventions
The therapy being considered is bariatric surgery.

Comparators
Comparators of interest include standard medical care. Treatment for preadolescent children with morbid obesity includes low carbohydrate dieting and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

The existing literature evaluating bariatric surgery as a treatment for morbid obesity has varying lengths of follow-up, ranging from 1 to 5 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Black et al. (2013; described above) published a systematic review of 23 studies on bariatric surgery in children and adolescents.¹⁴⁵

Clinical practice guidelines (e.g., from the Endocrine Society [2008]¹⁵³ and the Institute for Clinical Systems Improvement [2013]¹⁵⁴) have recommended against bariatric surgery in preadolescent children.

Section Summary: Bariatric Surgery in Morbidly Obese Preadolescent Children
There are few published data, and no studies were identified that focused on bariatric surgery in preadolescent children. Clinical guidelines have recommended against bariatric surgery in preadolescent children.

Hiatal Hernia Repair in Conjunction With Bariatric Surgery for Adults With Morbid Obesity and a Preoperative Diagnosis of Hiatal Hernia
Clinical Context and Therapy Purpose
The purpose of hiatal hernia repair with bariatric surgery is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard medical care, in patients with morbid obesity and a preoperative diagnosis of hiatal hernia

The question addressed in this evidence review is: Do various bariatric surgery procedures improve the net health outcome in adults who are obese with a preoperative diagnosis of hiatal hernia?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with morbid obesity and a preoperative diagnosis of hiatal hernia.

Interventions
The therapy being considered is hiatal hernia repair with bariatric surgery.

Comparators
Comparators of interest include standard medical care. Treatment for patients with morbid obesity and a preoperative diagnosis of hiatal hernia includes physical exercise, low carbohydrate dieting and low-fat dieting.

Outcomes
The general outcomes of interest are OS, change in disease status, functional outcomes, health status measures, quality of life, treatment-related mortality and treatment-related morbidity.

The existing literature evaluating hiatal hernia repair with bariatric surgery as a treatment for morbid obesity and a preoperative diagnosis of hiatal hernia has varying lengths of follow-up, ranging from 1 to 3 years. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. One-year follow-up is necessary to demonstrate weight loss efficacy. Longer follow-up to 5 to 10 years is desirable to assess maintenance of weight loss, impact on co-occurring conditions, and appearance of long-term complications.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Hiatal hernia is associated with obesity, and existing hiatal hernias may be worsened with bariatric surgery. In some studies, the presence of a hiatal hernia has been associated with complications after LAGB.¹⁵⁵ Although other studies have reported no differences in perioperative complications after LAGB in patients with GERD and/or a hiatal hernia or those without GERD and/or hiatal hernia.¹⁵⁶ Hiatal hernias, either incidentally found at surgery or diagnosed preoperatively, are often repaired at the time of bariatric surgery. In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons published guidelines on the management of hiatal hernia, recommending that, during RYGB, SG, and the placement of LAGBs, all detected hiatal hernias should be repaired (grade of recommendation: weak; evidence quality moderate).¹⁵⁷ There is limited evidence regarding whether repair of hiatal hernias at the time of bariatric surgery improves outcomes after surgery; it consists primarily of cohort studies comparing outcomes for patients who had a hiatal hernia and underwent repair during bariatric surgery with patients without a hiatal hernia.

Systematic Reviews
Chen et al. (2021) published a systematic review of 18 studies that evaluated outcomes after hiatal hernia repair plus SG in obese patients (N = 937).¹⁵⁸ Results demonstrated that patients who underwent hiatal hernia repair during SG had significant reductions in BMI (MD, -11.42 kg/m2, 95% CI, -12.8 to -10.03), and the risk of GERD symptoms (OR, 0.20; 95% CI, 0.10 to 0.41) and esophagitis (OR, 0.12; 95% CI, 0.05 to 0.26). Hiatal hernia repair during SG was superior to SG alone for GERD remission (OR, 2.97; 95% CI, 1.78 to 4.95), but not de novo GERD (OR, 0.61; 95% CI, 0.24 to 1.53). The pooled recurrence rate for hiatal hernia after hiatal hernia repair plus SG was 11% (95% CI, 4 to 19).

Cohort Studies
Gulkarov et al. (2008) reported on results of a prospective cohort study comparing outcomes for patients who underwent LAGB with or without concurrent hiatal hernia repair (n = 1,298 with LAGB alone; n = 520 with concurrent hiatal hernia repair).¹⁵⁹ The authors reported that, initially, hiatal hernias were diagnosed based on preoperative esophagram and upper endoscopy, but this was discontinued after these studies were shown to have poor predictive value for small-to-medium size hernias; subsequent patients were diagnosed at the time of surgery. It was not specified how many patients were diagnosed with each method or how many of those had symptoms before gastric banding. Fewer patients who underwent concurrent hiatal hernia repair required reoperation for a complication (3.5% versus 7.9% in the LAGB alone group; p < .001). Hiatal hernia repair added an average of 14 minutes to surgical time. Weight loss outcomes did not differ significantly between groups.

Santonicola et al. (2014) evaluated the effects of LSG with or without hiatal hernia repair on GERD in obese patients.¹⁶⁰ The study included 78 patients who underwent SG with concomitant hiatal hernia repair for a sliding hiatal hernia diagnosed intraoperatively, compared with 102 patients without a hiatal hernia who underwent SG only. The prevalence of typical GERD symptoms did not improve from baseline to follow-up in patients who underwent concomitant hiatal hernia repair (38.4% presurgery versus 30.8% postsurgery, p = .3). However, those in the SG only group had a significant decrease in the prevalence of typical GERD symptoms (39.2% presurgery versus 19.6% postsurgery, p = .003).

Reynoso et al. (2011) reported on outcomes after primary and revisional LAGB in patients with a hiatal hernia treated at a single hospital system.¹⁶¹ Of 1,637 patients with a hiatal hernia undergoing primary gastric banding, 190 (11.6%) underwent concurrent hiatal hernia repair; of 181 patients undergoing revision gastric banding, 15 (8.3%) underwent concurrent hiatal hernia repair. For primary procedures, there were no significant differences in mortality, morbidity, length of stay, and 30-day readmission rates for patients who underwent LAGB with and without hiatal hernia repair. However, this compares patients with a hiatal hernia undergoing repair to patients without a hiatal hernia. The more relevant comparison would be comparing repair to no repair in patients who have a hiatal hernia.

Ardestani et al. (2014) analyzed data from the Bariatric Outcomes Longitudinal Database registry to compare outcomes for patients with and without hiatal hernia repair at the time of LAGB.¹⁶² Of 41,611 patients who had LAGB from 2007 to 2010, 8,120 (19.5%) had a concomitant hiatal hernia repair. Those with hiatal hernia repair were more likely to have GERD preoperatively (49% versus 40% in the non-hiatal hernia repair group; p < .001). Perioperative outcomes were similar between groups. Of those with GERD preoperatively, rates of improvement in GERD symptoms did not differ significantly at 1 year, postprocedure (53% for hiatal hernia repair versus 52% for non-hiatal hernia repair; p = .4). Although the hiatal hernia repair added minimal time (mean, 4 minutes) to surgery, the authors concluded that many repairs would have involved small hernias with limited clinical effect.

In general, studies have reported that the addition of hiatal hernia repair at the time of bariatric surgery is safe and feasible. In a small case series of 21 patients, Frezza et al. (2008) described the feasibility of crural repair at the time of LAGB for patients with a hiatal hernia.¹⁶³ Al-Haddad et al. (2014) used data from the U.S. Nationwide Inpatient Sample to evaluate the surgical risk associated with hiatal hernia repair at the time of bariatric surgery.¹⁶⁴ For laparoscopic RYGB, there were 206,559 and 9,060 patients who underwent the procedure alone or with concomitant hiatal hernia repair, respectively. For LAGB, 52901 and 9893 patients, respectively, underwent the procedure alone or with hiatal hernia repair. The authors reported no evidence of increased risk of perioperative adverse events associated with the concomitant hiatal hernia repair. However, patients who underwent a concomitant hiatal hernia repair were less likely to have prolonged length of stay, with an average treatment effect of hiatal hernia repair of -0.124 (95% CI, -0.15 to -0.088) for prolonged length of stay for patients who underwent RYGB and an average treatment effect of hiatal hernia repair of -0.107 (95% CI, -0.159 to -0.0552) for prolonged length of stay for patients who underwent LAGB.

Section Summary: Hiatal Hernia Repair in Conjunction With Bariatric Surgery for Adults With Morbid Obesity and a Preoperative Diagnosis of Hiatal Hernia
Hiatal hernia repair is frequently undertaken at the time of bariatric surgery. The evidence related to whether hiatal hernia repair improves outcomes after bariatric surgery is limited, particularly for hiatal hernias that are incidentally diagnosed at the time of surgery. For patients with a preoperative diagnosis of a hiatal hernia, symptoms related to a hernia, and indications for surgical repair, it is reasonable to undertake this procedure at the time of bariatric surgery. For other patients, it is uncertain whether repair of a hiatal hernia at the time of bariatric surgery improves outcomes. A systematic review found that hiatal hernia repair during SG was superior to SG alone for GERD remission, but not de novo GERD.

Summary of Evidence
Adults with Morbid Obesity
For individuals who are adults with morbid obesity who receive gastric bypass, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. TEC Assessments and other systematic reviews of RCTs and observational studies found that gastric bypass improves health outcomes, including weight loss and remission of T2D. A TEC Assessment found similar weight loss with open and laparoscopic gastric bypass. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive LAGB, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that LAGB is a reasonable alternative to gastric bypass. There is less weight loss with LAGB than with gastric bypass, but LAGB is less invasive and is associated with fewer serious adverse events. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive SG, the evidence includes RCTs, observational studies (evaluating SG alone and comparing SG with gastric bypass), as well as systematic reviews. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that SG results in substantial weight loss and that this weight loss is durable for at least 5 years. A meta-analysis found that short-term weight loss was similar after SG compared with gastric bypass. Long-term weight loss was greater after gastric bypass, but SG is associated with fewer adverse events. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive BPD with DS, the evidence includes nonrandomized comparative studies, observational studies, and a systematic review. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Nonrandomized comparative studies have found significantly higher weight loss after BPD with DS compared with gastric bypass at 1 year. A large case series found sustained weight loss after 7 years. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive BPD without DS, the evidence includes observational studies and systematic reviews. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A TEC Assessment reviewed the available observational studies and concluded that weight loss was similar after BPD without a DS or gastric bypass. However, concerns have been raised about complications associated with BPD without DS, especially long-term nutritional and vitamin deficiencies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive VBG, the evidence includes observational studies and systematic reviews. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A TEC Assessment identified 8 nonrandomized comparative studies evaluating VBG, and these studies found that weight loss was significantly greater with open gastric bypass. Moreover, VBG has relatively high rates of complications, revisions, and reoperations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive 2-stage bariatric surgery procedures, the evidence includes a small RCT, observational studies, and case series. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is a lack of evidence that 2-stage bariatric procedures improve outcomes compared with 1-stage procedures. The small RCT compared IGB plus gastric bypass with the standard of care plus gastric bypass and did not detect a difference in weight loss at 6 months postsurgery. Case series have shown relatively high complication rates in 2-stage procedures, and patients are at risk of complications in both stages. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive laparoscopic gastric plication, the evidence includes an RCT, an observational study , and systematic reviews. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A 2021 systematic review demonstrated that laparoscopic SG is superior to laparoscopic greater curvature gastric plication with regard to providing effective weight loss through 24 months; statistical significance was not reached at 36 months. The difference in the improvement of comorbidities and risk of major complications or mortality did not reach statistical significance between groups. One additional RCT compared endoscopic gastric plication with a sham procedure, reporting 1-year follow-up results in favor of the intervention. Additional comparative studies and RCTs with longer follow-up are needed to permit conclusions about the safety and efficacy of laparoscopic gastric plication. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive SADI-S, the evidence includes a systematic review of observational studies and case series. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A systematic review of 12 observational studies concluded that SADI-S was associated with promising weight loss and comorbidity resolution. A comparative chart review found that patients without diabetes experienced significantly better weight loss and lipid profiles with SADI-S than with RYGB and patients who had diabetes experienced significantly higher rates of remission with SADI-S than with RYGB. Comparative studies and especially RCTs are needed to permit conclusions about the safety and efficacy of SADI-S. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive a duodenojejunal sleeve, the evidence includes RCTs, systematic reviews, and an observational study. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A systematic review of duodenojejunal sleeves included 5 RCTs and found significantly greater short-term weight loss (12 to 24 weeks) with the sleeves compared with medical therapy. There was no significant difference in symptoms associated with diabetes. All RCTs were small and judged by systematic reviewers to be at high-risk of bias. High-quality comparative studies are needed to permit conclusions on the safety and efficacy of the procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive IGB devices, the evidence includes RCTs, systematic reviews, and case series. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. RCTs assessing the 2 IGB devices approved by the U.S. Food and Drug Administration have found significantly greater weight loss with IGB than with sham treatment or lifestyle therapy alone after 6 months (maximum length of device use). Some adverse events were reported, mainly related to accommodation of the balloon in the stomach; in a minority of cases, these adverse events were severe. One RCT followed patients for an additional 6 months after IGB removal and found sustained weight loss. There are limited data on the durability of weight loss in the long-term. Comparative data are lacking. A large case series found that patients gradually regained weight over time. Moreover, it is unclear how 6 months of IGB use would fit into a long-term weight loss and maintenance intervention. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive an AT device, the evidence includes an RCT and case series. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. The RCT found significantly greater weight loss with AT than lifestyle therapy at 1 year. Forty of 58 patients (69%) achieved at least 10% total weight loss at 4 years or at time of study withdrawal; however, only 15/111 initial AT patients completed the study through 4 years. In addition to a high degree of missing data, the PATHWAY study noted a potentially large number of adverse events related to A-tube malfunction, an element of the therapy which is expected to require replacement within approximately 3.5 years postgastrostomy in 50% of cases. The impact of this on health outcomes compared to existing surgical approaches is unknown. One small case series reported on 15 patients at 2 years. The total amount of data on AT remains limited and additional studies are needed before conclusions can be drawn about the effects of treatment on weight loss, metabolism, safety, nutrition, and long-term durability of treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Revision Bariatric Surgery
For individuals who are adults with morbid obesity and failed bariatric surgery who receive revision bariatric surgery, the evidence includes systematic reviews, case series, and registry data. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews and case series have shown that patients receiving revision bariatric surgery experienced satisfactory weight loss. Data from a multinational bariatric surgery database has found that corrective procedures following primary bariatric surgery are relatively uncommon but generally safe and efficacious. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Adults With Type 2 Diabetes
For individuals who are diabetic and not morbidly obese who receive gastric bypass, SG, BPD or LAGB, the evidence includes systematic reviews of RCTs and observational studies. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that certain types of bariatric surgery are more efficacious than medical therapy as a treatment for Type 2 diabetes in obese patients, including those with a BMI between 30 and 34.9 kg/m². The greatest amount of evidence is on gastric bypass. Systematic reviews have found significantly greater remission rates of diabetes, decrease in hemoglobin A1c levels, and decrease in BMI with bariatric surgery than with nonsurgical treatment. The efficacy of surgery is balanced against the short-term risks of the surgical procedure. Most RCTs in this population have 1 to 3 years of follow-up; with a few having 5-year follow-up data. There are clinical concerns about durability and long-term outcomes at 5 to 10 years as well as potential variation in observed outcomes in community practice versus clinical trials. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Nondiabetic and Nonobese Adults
For individuals who are not diabetic and not morbidly obese who receive any bariatric surgery procedure, the evidence includes RCTs, nonrandomized comparative studies, and case series. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is limited evidence for bariatric surgery in patients who are not diabetic or morbidly obese. A few small RCTs and case series have reported a loss of weight and improvements in comorbidities for this population. However, the evidence does not permit conclusions on the long-term risk-benefit ratio of bariatric surgery in this population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Adolescent Children with Morbid Obesity Gastric Bypass, Laparoscopic Adjustable Gastric Banding or Sleeve Gastrectomy
For individuals who are adolescent children with morbid obesity who receive gastric bypass or LAGB or SG, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of studies on bariatric surgery in adolescents, who mainly received gastric bypass or LAGB or SG, found significant weight loss and reductions in comorbidity outcomes with bariatric surgery. For bariatric surgery in the adolescent population, although data are limited on some procedures, studies have generally reported that weight loss and reduction in risk factors for adolescents are similar to that for adults. Most experts and clinical practice guidelines have recommended that bariatric surgery in adolescents be reserved for individuals with severe comorbidities, or for individuals with a BMI greater than 50 kg/m². Also, greater consideration should be placed on the patient developmental stage, on the psychosocial aspects of obesity and surgery, and on ensuring that the patient can provide fully informed consent. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Bariatric Surgery Other Than Gastric Bypass, Laparoscopic Adjustable Gastric Banding or Sleeve Gastrectomy
For individuals who are adolescent children with morbid obesity who receive bariatric surgery other than gastric bypass or LAGB or SG, the evidence includes systematic reviews and a cohort study. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Studies using bariatric surgery other than gastric bypass, LAGB, or SG, have small sample sizes. Results from a meta-analysis including patients using other procedures have shown significant improvements in BMI reduction, fasting blood insulin, and total cholesterol, although the estimates have wide CIs, limiting interpretation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Preadolescent Children With Morbid Obesity
For individuals who are preadolescent children with morbid obesity who receive bariatric surgery, there are no studies focused on this population. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Several studies of bariatric surgery in adolescents have also included children younger than 12 years old, but findings were not reported separately for preadolescent children. Moreover, clinical practice guidelines have recommended against bariatric surgery for preadolescent children. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Hiatal Hernia Repair With Bariatric Surgery
For individuals with morbid obesity and a preoperative diagnosis of a hiatal hernia who receive hiatal hernia repair with bariatric surgery, the evidence includes a systematic review, cohort studies, and case series. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A systematic review found that hiatal hernia repair during SG was superior to SG alone for GERD remission, but not de novo GERD. Results from the cohort studies and case series have shown that, when a preoperative diagnosis of a hiatal hernia has been present, repairing the hiatal hernia during bariatric surgery resulted in fewer complications. However, the results are limited to individuals with a preoperative diagnosis. There was no evidence on the use of hiatal hernia repair when the hiatal hernia diagnosis is incidental. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2008 Input
In response to the requests, input was received from 1 physician specialty society and 2 academic medical centers on the use of the REALIZE band while the policy was under review in 2008. All 3 responses supported the use of the REALIZE band as a surgical option for patients, as adopted into the policy in 2008.

In response to the requests, input was also received from 2 academic medical centers on the use of the new endoscopic placement of devices to remedy weight gain that occurs after bariatric surgery while the policy was under review in 2008. Input from both centers agreed that this approach is considered investigational, as adopted in the policy in 2008.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Association of Clinical Endocrinologists et al.
In 2020, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology jointly published a comprehensive diabetes Type 2 management algorithm.¹⁶⁵ The document stated: “Bariatric surgery should be considered for adult patients with a BMI [body mass index] of 35 kg/m² or more and comorbidities, especially if therapeutic goals have not been reached using other modalities. A successful outcome of surgery usually requires a long-term outpatient commitment to follow-up and support.”

In 2016, the AACE and the American College of Endocrinology jointly published comprehensive clinical guidelines on the medical care of patients with obesity.¹⁶⁶ The guidelines addressed 9 broad clinical questions with 123 recommendations. With regard to bariatric surgery, the following recommendations were added (Table 22).

Table 22. Recommendations for Bariatric Surgery Added in 2016

No.	Recommendation	GOE	BEL
35	Patients with obesity (BMI ≥30 kg/m2) and diabetes who have failed to achieve targeted clinical outcomes following treatment with lifestyle therapy and weight-loss medications may be considered for bariatric surgery, preferably Roux-en-Y gastric bypass, sleeve gastrectomy, or biliopancreatic diversion.”	B	1a
121	“Patients with a BMI of ≥ 35 kg/m2 and 1 or more severe obesity-related complications, including type 2 diabetes, hypertension, obstructive sleep apnea, obesity-hypoventilation syndrome, Pickwickian syndrome, nonalcoholic fatty liver disease or nonalcoholic steatohepatitis, pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life may also be considered for a bariatric surgery procedure. Patients with BMI of 30 to 34.9 kg/m2 with diabetes or metabolic syndrome may also be considered for a bariatric procedure, although current evidence is limited by the number of patients studied and lack of long-term data demonstrating net benefit. BMI ≥ 35 kg/m2 and therapeutic target of weight control and improved biochemical markers of CVD risk. BMI ≥ 30 kg/m2 and therapeutic target of weight control and improved biochemical markers of CVD risk. BMI ≥ 30 kg/m2 and therapeutic target of glycemic control in Type 2 diabetes and improved biochemical markers of CVD risk.	A B C	1 2 3
122	“Independent of BMI criteria, there is insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, lipid lowering alone, or CVD risk reduction alone.”	D
62	“Roux-en-Y gastric bypass should be considered as the bariatric surgery procedure of choice for patients with obesity and moderate to severe gastroesophageal reflux symptoms, hiatal hernia, esophagitis, or Barrett’s esophagus.”“Intragastric balloon for weight loss may increase gastroesophageal reflux symptoms and should not be used for weight loss in patients with established gastroesophageal reflux.”	Int Strong	Int Strong

BEL: best evidence level; BMI: body mass index; CVD: cardiovascular disease; GOE: grade of evidence; Int: intermediate.
^a Downgraded due to study limitations.

In 2019, an update of the joint 2013 guidelines on support for bariatric surgery patients were published by the AACE, the Obesity Society, the American Society for Metabolic and Bariatric Surgery (ASMBS), Obesity Medicine Association, and American Society of Anesthesiologists.^167, Recommendations on the following questions are summarized below.

• “Which patients should be offered bariatric surgery?”

  • “Patients with a BMI ≥ 40 kg/m² without coexisting medical problems and for whom bariatric surgery would not be associated with excessive risk should be eligible for a bariatric procedure.”

  • “Patients with a BMI ≥ 35 kg/m² and 1 or more severe obesity-related complications remediable by weight loss, including T2D, high risk for T2D, poorly controlled hypertension, nonalcoholic fatty liver disease/nonalcoholic steatohepatitis, OSA, osteoarthritis of the knee or hip, and urinary stress incontinence, should be considered for a bariatric procedure.”

  • "Patients with the following comorbidities and BMI ≥ 35 kg/m² may also be considered for a bariatric procedure, though the strength of evidence is more variable; obesity-hypoventilation syndrome and Pickwickian syndrome after a careful evaluation of operative risk; idiopathic intracranial hypertension; GERD; severe venous stasis disease; impaired mobility due to obesity, and considerably impaired quality of life."

  • “Patients with BMI of 30 to 34.9 kg/m² with T2D with inadequate glycemic control despite optimal lifestyle and medical therapy should be considered for a bariatric procedure; current evidence is insufficient to support recommending a bariatric procedure in the absence of obesity."

  • "The BMI criterion for bariatric procedures should be adjusted for ethnicity (e.g., 18.5 to 22.9 kg/m² is normal range, 23 to 24.9 kg/m² overweight, and ≥ 25 kg/m² obesity for Asians)."

  • "Bariatric procedures should be considered to achieve optimal outcomes regarding health and quality of life when the amount of weight loss needed to prevent or treat clinically significant obesity-related complications cannot be obtained using only structured lifestyle change with medical therapy."

• “Which bariatric surgical procedure should be offered?”

  • “Selecting a bariatric procedure should be based on individualized goals of therapy (e.g., weight loss target and/or improvement in specific obesity-related complications), available local-regional expertise (obesity specialists, bariatric surgeon, and institution), patient preferences, personalized risk stratification, and other nuances as they become apparent. Notwithstanding technical surgical reasons, laparoscopic bariatric procedures should be preferred over open bariatric procedures due to lower early postoperative morbidity and mortality. Laparoscopic adjustable gastric banding, sleeve gastrectomy, RYGB, and LBPD/DS, or related procedures should be considered as primary bariatric and metabolic procedures performed in patients requiring weight loss and/or amelioration of obesity-related complications. Physicians must exercise caution when recommending BPD, BPD with duodenal switch, or related procedures because of the greater associated nutritional risks related to the increased length of bypassed small intestine. Newer nonsurgical bariatric procedures may be considered for selected patients who are expected to benefit from short-term (ie, about 6 months) intervention with ongoing and durable structured lifestyle with/without medical therapy."

American College of Cardiology et al.
In 2013, the American College of Cardiology, American Heart Association, and the Obesity Society published joint guidelines on the management of obesity and overweight in adults. The guidelines made the following recommendations related to bariatric surgery:

• “Advise adults with a BMI 40kg/m² or BMI 35 kg/m² with obesity-related comorbid conditions who are motivated to lose weight and who have not responded to behavioral treatment with or without pharmacotherapy with sufficient weight loss to achieve targeted health outcome goals that bariatric surgery may be an appropriate option to improve health and offer referral to an experienced bariatric surgeon for consultation and evaluation. NHLBI Grade A (Strong); AHA/ACC COR [class of recommendation]: IIa; AHA/ACC LOE [level of evidence]: A”
• “For individuals with a BMI < 35 kg/m², there is insufficient evidence to recommend for or against undergoing bariatric surgical procedures. NHLBI Grade N (No Recommendation)”

American Society for Metabolic and Bariatric Surgery
In 2016, the ASMBS published a position statement on intragastric balloon therapy (the statement was also endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons).¹⁶⁸ The statement did not include specific recommendations for or against using these devices. A summary of key recommendations is as follows:

There is level 1 data from RCTs [randomized controlled trials] on the “efficacy [and] safety of intragastric balloon therapy for obesity … [and] lower-level evidence [suggesting] that weight loss can be maintained … for some finite time into the future.”

It is difficult to separate the effect from the intragastric “balloon alone from those of supervised diet and lifestyle changes.” This has been addressed in recent FDA [U.S. Food and Drug Administration] pivotal trials. “In general, any obesity treatment, including intragastric balloon therapy, would benefit from a multidisciplinary team.”

“…serious complications are rare. Early postoperative tolerance challenges … can be managed with pharmacotherapy in the majority of patients.”

In 2017, the ASMBS published a position statement on sleeve gastrectomy.¹⁶⁹ This updated statement provided the following conclusions:

• “Substantial long-term outcome data published in the peer-reviewed literature, including studies comparing outcomes of various surgical procedures, confirm that sleeve gastrectomy [SG] provides significant and durable weight loss, improvements in medical comorbidities, improved quality of life, and low complication and mortality rates for obesity treatment."

• "In terms of initial early weight loss and improvement of most weight-related comorbid conditions, SG and RYGB appear similar. The effect of SG on GERD, however, is less clear, because GERD improvement is less predictable and GERD may worsen or develop de novo."

• The ASMBS recognizes SG as an acceptable option for a primary bariatric procedure or as a first-stage procedure in high-risk patients as part of a planned staged approach."

Surgeons performing SG are encouraged to continue to prospectively collect and report outcome data in the peer-reviewed scientific literature.

In 2018, the ASMBS and the American Hernia Society published a consensus guideline on bariatric surgery and hernia surgery.¹⁷⁰ The guideline contained the following conclusions and summary recommendations:

• "There is a significant link between obesity and hernia formation both after abdominal surgery and de novo. There is also evidence that abdominal wall hernia can more commonly present with obstruction or strangulation in patients with obesity."

• "There is a higher risk for complications and recurrence after hernia repair in patients with obesity."

• "In patients with severe obesity and ventral hernia, and both being amenable to laparoscopic repair, combined hernia repair and metabolic/bariatric surgery may be safe and associated with good short-term outcomes and low risk of infection. There is a relative lack of evidence, however, about the use of synthetic mesh in this setting."

• "In patients with severe obesity and abdominal wall hernia that is not amenable to laparoscopic repair, a staged approach is recommended. Weight loss prior to hernia repair is likely to improve hernia repair outcomes. Metabolic/bariatric surgery appears to provide far more significant and rapid weight loss than other modalities and would be a good option for selected patients with severe obesity and large, symptomatic abdominal wall hernia."

In 2020, ASMBS published an updated statement on single-anastomosis duodenal switch (SADI-S) "in response to numerous inquiries made ... by patients, physicians, society members, hospitals, and others regarding [this procedure] as a treatment for obesity and metabolic diseases."¹⁷¹ The following recommendations were endorsed regarding SADI-S for the primary treatment of obesity or metabolic disease:

• "SADI-S, a modification of classic Roux-en-Y duodenal switch, is an appropriate metabolic bariatric surgical procedure."

• "Publication of long-term safety and efficacy outcomes is still needed and is strongly encouraged, particularly with published details on sleeve gastrectomy size and common channel length."

• "There remain concerns about intestinal adaptation, nutritional issues, optimal limb lengths, and long-term weight loss/regain after this procedure. As such, ASMBS recommends a cautious approach to the adoption of this procedure, with attention to ASMBS-published guidelines on nutritional and metabolic support of bariatric patients, in particular for duodenal switch patients."

Society of American Gastrointestinal and Endoscopic Surgeons
In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons issued evidence-based guidelines on the management of a hiatal hernia, which included a recommendation about the repair of hiatal hernias incidentally detected at the time of bariatric surgery.¹⁵⁷ These guidelines stated: “During operations for Roux-en-Y gastric bypass, sleeve gastrectomy and the placement of adjustable gastric bands, all detected hiatal hernias should be repaired” (moderate quality evidence, weak recommendation).

International Federation for the Surgery of Obesity and Metabolic Disorders
In 2019, members of societies affiliated with the International Federation for the Surgery of Obesity and Metabolic Disorders established an expert consensus statement on revisional bariatric surgery (RBS).¹⁷² Consensus agreement was established for the following recommendation statements:

• "RYGB is an acceptable RBS option after gastric banding."

• "OAGB is an acceptable RBS option after gastric banding."

• "SADI-S is an acceptable RBS option after gastric banding."^a

• "RBS after gastric banding can be carried out in either 1 or 2 stage."

• "OAGB is an acceptable RBS option after SG."

• "BPD-DS is an acceptable RBS option after SG."

• "SADI-S is an acceptable RBS option after SG."

• "Prolongation of bilio-pancreatic limb is an acceptable RBS option after RYGB."

• "Prolongation of bilio-pancreatic limb is an acceptable RBS option after OAGB."^a

BPD-DS: bilio-pancreatic diversion duodenal switch; OAGB: one gastric bypass; RBS: revisional bariatric surgery; RYGB: Roux-en-Y gastric bypass; SADI: single anastomosis duodeno-ileal bypass with sleeve gastrectomy; SG: sleeve gastrectomy.

^a Consensus achieved in second round of voting.

In 2020, members of societies affiliated with the International Federation for the Surgery of Obesity and Metabolic Disorders established a position statement on Single Anastomosis Duodenal-Ileal Bypass with Sleeve Gastrectomy/One Anastomosis Duodenal Switch (SADI-S/OADS).¹⁷³ The following recommendations were made based on available data:

• SADI-S/OADS offers substantial weight loss that is maintained into the medium term."

• "SADI-S/OADS provides an improvement in metabolic health that is maintained into the medium term."

• "Nutritional deficiencies are emerging as long-term safety concerns for the SADI-S/OADS procedure and patients undergoing this procedure need to be aware of this, and counseled to stay in long-term multidisciplinary care."

• "Surgeons performing the SADI-/OADS, as well as other bariatric/metabolic procedures, are encouraged to participate in a national or international registry so that data may be more effectively identified."

• "IFSO supports the SADI-S/OADS as a recognized bariatric/metabolic procedure, but highly encourages RCT’s in the near future."

Guidelines for Children and Adolescents
Childerhose et al. (2017) conducted a systematic review of adolescent bariatric surgery recommendation documents published in the United States and provided recommendations based on their review.¹⁷⁴ The literature search was conducted from 1,999 through 2013 and identified 16 recommendations for inclusion: 10 clinical practice guidelines, 4 position statements, and 2 consensus statements. Fifteen of the 16 publications recommended bariatric surgery for adolescents. The main reasons for recommending bariatric surgery for adolescents included: (1) surgery is effective in producing short- and long-term weight loss; (2) surgery is appropriate when the patient does not respond to behavioral or medical interventions; (3) surgery is appropriate when serious comorbidities threaten the health of the patient; and (4) surgery can improve long-term health and/or emotional problems. Body mass index thresholds ranged from 35 kg/m² or more to 50 kg/m² or more, with lower thresholds usually requiring the presence of at least 1 serious comorbidity. The minimum age was specified in 10 publications, with most using physiologic maturity (Tanner stage IV and/or 95% of adult height based on bone age, corresponding to ≥ 13 years for females and to ≥ 15 years for males) rather than years.

American Academy of Pediatrics
In 2019, the American Academy of Pediatrics (AAP) published a report outlining the current evidence regarding adolescent bariatric surgery that provided recommendations for practitioners and policy makers.¹⁷⁵ Within this report, AAP listed indications for adolescent metabolic and bariatric surgery (Table 23) that reflected 2018 ASMBS recommendations. Additionally, the AAP report noted that generally accepted contraindications to bariatric surgery included: "a medically correctable cause of obesity, untreated or poorly controlled substance abuse, concurrent or planned pregnancy, current eating disorder, or inability to adhere to postoperative recommendations and mandatory lifestyle changes."

Table 23. Indications for Adolescent Metabolic and Bariatric Surgery

Weight Criteria	Comorbid Conditions
Class 2 obesity; BMI ≥35, or 120% of the 95th percentile for age and sex, whichever is lower Class 3 obesity; BMI ≥ 40, or 140% of the 95th percentile for age and sex, whichever is lower	Clinically significant disease, including OSA (AHI > 5), T2D, IIH, NASH, Blount disease, SCFE, GERD, and hypertension Not required but commonly present

AHI: apnea-hypopnea index; BMI: body mass index; GERD: gastroesophageal reflux disease; IIH: idiopathic intracranial hypertension; NASH: non-alcoholic steatohepatitis; OSA: obstructive sleep apnea; SCFE: slipped capital femoral epiphysis; T2D: type 2 diabetes.

American Society for Metabolic and Bariatric Surgery
In 2012, the ASMBS best practice guidelines found that current evidence was insufficient to discriminate among specific bariatric procedures, but allowed that there was an increasing body of data showing safety and efficacy of Roux-en-Y gastric bypass and adjustable gastric band for the pediatric population.¹⁷⁶ Bariatric surgery was recommended for pediatric patients with morbid obesity and the following comorbidities:

Strong indications:

• Type 2 diabetes

• Moderate or severe obstructive sleep apnea (apnea-hypopnea index > 15)

• Nonalcoholic steatohepatitis

• Pseudotumor cerebri

Less strong indications:

• Cardiovascular disease

• Metabolic syndrome.

The guidelines stated that depression and eating disorders should not be considered exclusion criteria for bariatric surgery. The guidelines also noted that depression should be monitored following the procedure and that eating disorders should be treated and the patient stabilized before the procedure.

In 2018, ASBMS published an update to the 2012 guideline.¹⁷⁷ Summary of major changes in the guideline included:

• "Vertical sleeve gastrectomy has become the most used and most recommended operation in adolescents with severe obesity for several reasons, near-equivalent weight loss to RYGB in adolescents, fewer reoperations, better iron absorption, and near-equivalent effect on comorbidities as RYGB in adolescents. However, given the more extensive long-term data available for RYGB, we can recommend the use of either RYGB or VSG in adolescents. Long-term outcomes of GERD after vertical sleeve gastrectomy are still not well understood."

• "There are no data that the number of preoperative weight loss attempts correlated with success after metabolic/bariatric surgery. Compliance with a multidisciplinary preoperative program may improve outcomes after metabolic/bariatric surgery but prior attempts at weight loss should be removed as a barrier to definitive treatment for obesity."

• "The use of the most up to date definitions of childhood obesity are as follows: (1) BMI cut offs of 35 kg/m² or 120% of the 95th percentile with a comorbidity, or (2) BMI > 40 kg/m² or 140% of the 95th percentile without a comorbidity (whichever is less). Requiring adolescents with a BMI > 40 to have a comorbidity (as in the old guidelines) puts children at a significant disadvantage to attaining a healthy weight. Earlier surgical intervention (at a BMI < 45 kg/m²⁾ can allow adolescents to reach a normal weight and avoid lifelong medication therapy and end organ damage from comorbidities."

• "Certain comorbidities should be considered in adolescents, specifically the psychosocial burden of obesity, the orthopedic diseases specific to children, GERD, and cardiac risk factors. Given the poor outcomes of medical therapies for T2D in children, these comorbidities may be considered an indication for metabolic/bariatric surgery in younger adolescents or those with lower obesity percentiles."

• "Vitamin B deficiencies, especially B1 appear to be more common in adolescents both preoperatively and postoperatively; they should be screened for and treated. Prophylactic B1 for the first 6 months postoperatively is recommended as is education of patients and primary care providers on the signs and symptoms of common deficiencies."

• "Developmental delay, autism spectrum or syndromic obesity should not be a contraindication to metabolic/bariatric surgery. Each patient and caregiver team will need to be assessed for the ability to make dietary and lifestyle changes required for surgery. Multidisciplinary teams should agree on the specific needs and abilities of the given patient and caregiver and these should be considered on a case-by-case basis with the assistance of the hospital ethics committee where appropriate."

• "Because metabolic/bariatric surgery results in better weight loss and resolution of comorbidities in adolescents at lower BMI’s with fewer comorbidities, referrals should occur early, as soon as a child is recognized to suffer from severe obesity disease (BMI > 120% of the 95th percentile or BMI of 35). Prior weight loss attempts, Tanner stage, and bone age should not be considered when referring patients to a metabolic/bariatric surgery program."

• "Unstable family environments, eating disorders, mental illness, or prior trauma should not be considered contraindications for metabolic/bariatric surgery in adolescents; however, these should be optimized and treated where possible before and surrounding any surgical intervention for obesity."

• "Routine screening of alcohol use is imperative across all procedures. Conservative clinical care guidelines, which strongly advocate abstinence, while appropriate, must also include information for this age group on harm reduction (i.e., lower consumption levels, how to avoid or manage situations related to alcohol-related harm) to mitigate clinical and safety risks. Risks of nicotine should be discussed and smoking or vaping nicotine should be discouraged."

• "The recognition of obesity as a chronic disease that requires multimodal therapies justifies the treatment of such a disease in a multidisciplinary team that can provide surgical, pharmacologic, behavioral, nutritional, and activity interventions. Pharmacologic therapies as adjuncts to surgical therapies may provide improved outcomes long term in the pediatric population; more studies are needed."

European Society for Gastroenterology, Hepatology and Nutrition et al.
In 2015, a joint position paper published by the European Society for Gastroenterology, Hepatology and Nutrition and the North American Society for Gastroenterology, Hepatology and Nutrition made the following recommendations on indications for bariatric surgery in adolescents¹⁷⁸:

• “BMI > 40 kg/m² with severe comorbidities

• Type 2 diabetes mellitus

• Moderate-to-severe sleep apnea

• Pseudotumor cerebri

• NASH [nonalcoholic steatohepatitis] with advanced fibrosis (ISHAK score > 1)

• BMI > 50 kg/m² with mild comorbidities

• Hypertension

• Dyslipidemia

• Mild obstructive sleep apnea

• Chronic venous insufficiency

• Panniculitis

• Urinary incontinence

• Impairment in activities of daily living

• NASH

• Gastroesophageal reflux disease

• Severe psychological distress

• Arthropathies related to weight.”

• Additional criteria included:

  • “Have attained 95% of adult stature

  • Have failed to attain a healthy weight with previously organized behavioral/medical treatments

  • Demonstrate commitment to psychological evaluation perioperatively

  • Avoid pregnancy for 1 year after surgery…

  • Have decisional capacity and will provide informed assent/consent, as age appropriate.”

Endocrine Society
In 2008, the Endocrine Society published recommendations on the prevention and treatment of pediatric obesity.¹⁵³ In 2017, the Society sponsored an update of these guidelines by the Pediatric Endocrine Society and the European Society of Endocrinology.¹⁷⁹ These guidelines recommended the following:

“We suggest that bariatric surgery be considered only under the following conditions:

• The child has attained Tanner 4 or 5 pubertal development and final or near-final adult height.
• The child has a BMI > 40 kg/m² or has BMI above 35 kg/m² and significant, extreme comorbidities.
• Extreme obesity and comorbidities persist, despite compliance with a formal program of lifestyle modification, with or without a trial of pharmacotherapy.
• Psychological evaluation confirms the stability and competence of the family unit.
• There is access to an experienced surgeon in a pediatric bariatric surgery center of excellence that provides the necessary infrastructure for patient care, including a team capable of long-term follow-up of the metabolic and psychosocial needs of the patient and family.
• The patient demonstrates the ability to adhere to the principles of healthy dietary and activity habits.

We recommend against bariatric surgery for preadolescent children, for pregnant or breast-feeding adolescents (and those planning to become pregnant within 2 yr of surgery) and in any patient who has not mastered the principles of healthy dietary and activity habits and/or has an unresolved substance abuse, eating disorder, or untreated psychiatric disorder.”

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 24.

Table 24. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT03493620	Multicenter Randomized Prospective Study With Sham Group to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity	60	Aug 2020 (unknown)
NCT03102697	Optimization and Follow-Up of the Consecutive Use of Two Intragastric Balloons in the Treatment of Obesity	30	Dec 2020 (unknown)
NCT01172899	The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery	60	Dec 2022 (active, not recruiting)
NCT02390973	Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)	408	Mar 2024 (recruiting)
NCT04174768	The Effect of Bariatric Surgery on Glucose Metabolism and Kidney Function	50	Nov 2021 (unknown)
NCT03891056	Metabolic Surgery for Patients with Type 2 DM and Grade 1 Obesity with Bad Metabolic Control (MSO1CT)	40	Jan 2022 (recruiting)
NCT02310178	Obesity Cohort: Medical Follow-Up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery	750	May 2022 (recruiting)
NCT02328599	A Prospective Consortium Evaluating the Long-term Follow-up of Patients With Type 2 Diabetes Enrolled In a Randomized Controlled Trial Comparing Bariatric Surgery Versus Medical Management (ARMMS-T2D)	302	Jun 2022 (enrolling by invitation)
NCT04583683	Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities: a Randomized Controlled Trial	218	Sep 2022 (active, not recruiting)
NCT03610256	Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of single anastomosis- Duodeno Ileal Bypass With Sleeve Gastrectomy (SADI-S) Versus Roux-en-Y Gastric Bypass (RYGB) (SADISLEEVE)	366	Oct 2023 (recruiting)
NCT03517072	Determinants of the Long-Term Success of Bariatric Surgery	1000	Jan 2023 (recruiting)
NCT03472157	Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH (NASHSURG)	100	Mar 2023 (recruiting)
NCT04506190	A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Laparoscopic and Robotic-Assisted Revisional Bariatric Surgery	200	Sep 2022 (recruiting)
NCT04128995	Surgical or Medical Treatment for Pediatric Type 2 Diabetes	90	Aug 2024 (recruiting)
NCT03236142	The Single, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial	110	Jan 2025 (recruiting)
NCT02692469	Laparoscopic single anastomosis- Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch as a Primary Bariatric Procedure. 5 Year Patient Follow	140	Apr 2026 (not yet recruiting)
NCT04165694	Single Anastomosis Duodenal Ileal Bypass (SADI) as a Second Stage for Sleeve Gastrectomy Weight Loss Failure	50	Dec 2030 (recruiting)
Unpublished
NCT02881684a	Weight Reduction by Aspiration Therapy in Asian Patients with Morbid Obesity	15	Dec 2018 (unknown)
NCT02142257	Gastric Bypass Procedure and AspireAssist Aspiration Therapy System for the Treatment of Morbid Obesity, Observational Study over 5 Years	100	May 2020 (unknown)

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.

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150. Willcox K, Brennan L. Biopsychosocial outcomes of laparoscopic adjustable gastric banding in adolescents: a systematic review of the literature. Obes Surg. Sep 2014;24(9):1510-1519. PMID 24849913
151. Nadler EP, Youn HA, Ren CJ, et al. An update on 73 US obese pediatric patients treated with laparoscopic adjustable gastric banding: comorbidity resolution and compliance data. J Pediatr Surg. Jan 2008;43(1):141-146. PMID 18206472
152. Manco M, Mosca A, De Peppo F, et al. The Benefit of Sleeve Gastrectomy in Obese Adolescents on Nonalcoholic Steatohepatitis and Hepatic Fibrosis. J Pediatr. Jan 2017; 180: 31-37.e2. PMID 27697327
153. August GP, Caprio S, Fennoy I, et al. Prevention and treatment of pediatric obesity: an Endocrine Society clinical practice guideline based on expert opinion. J Clin Endocrinol Metab. Dec 2008;93(12):4576-4599. PMID 18782869
154. Fitch A, Fox C, Bauerly K, et al. Health Care Guideline: Prevention and Management of Obesity for Children and Adolescents. Institute for Clinical Systems Improvement. 2013; https://www.healthpartners.com/ucm/groups/public/@hp/@public/documents/documents/cntrb_037112.pdf. Accessed December 28, 2021.
155. Greenstein RJ, Nissan A, Jaffin B. Esophageal anatomy and function in laparoscopic gastric restrictive bariatric surgery: implications for patient selection. Obes Surg. Apr 1998;8(2):199-206. PMID 9730394
156. Pilone V, Vitiello A, Hasani A, et al. Laparoscopic adjustable gastric banding outcomes in patients with gastroesophageal reflux disease or hiatal hernia. Obes Surg. Feb 2015;25(2):290-294. PMID 25030091
157. Kohn GP, Price RR, DeMeester SR, et al. Guidelines for the management of hiatal hernia. Surg Endosc. Dec 2013;27(12):4409-4428. PMID 24018762
158. Chen W, Feng J, Wang C, et al. Effect of Concomitant Laparoscopic Sleeve Gastrectomy and Hiatal Hernia Repair on Gastroesophageal Reflux Disease in Patients with Obesity: a Systematic Review and Meta-analysis. Obes Surg. Sep 2021; 31(9): 3905-3918. PMID 34254259
159. Gulkarov I, Wetterau M, Ren CJ, et al. Hiatal hernia repair at the initial laparoscopic adjustable gastric band operation reduces the need for reoperation. Surg Endosc. Apr 2008;22(4):1035-1041. PMID 18080712
160. Santonicola A, Angrisani L, Cutolo P, et al. The effect of laparoscopic sleeve gastrectomy with or without hiatal hernia repair on gastroesophageal reflux disease in obese patients. Surg Obes Relat Dis. Mar-Apr 2014;10(2):250-255. PMID 24355324
161. Reynoso JF, Goede MR, Tiwari MM, et al. Primary and revisional laparoscopic adjustable gastric band placement in patients with hiatal hernia. Surg Obes Relat Dis. May-Jun 2011;7(3):290-294. PMID 21130046
162. Ardestani A, Tavakkoli A. Hiatal hernia repair and gastroesophageal reflux disease in gastric banding patients: analysis of a national database. Surg Obes Relat Dis. May-Jun 2014;10(3):438-443. PMID 24680760
163. Frezza EE, Barton A, Wachtel MS. Crural repair permits morbidly obese patients with not large hiatal hernia to choose laparoscopic adjustable banding as a bariatric surgical treatment. Obes Surg. May 2008;18(5):583-588. PMID 18317857
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169. Ali M, El Chaar M, Ghiassi S, et al. American Society for Metabolic and Bariatric Surgery updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. Oct 2017; 13(10): 1652-1657. PMID 29054173
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172. Mahawar KK, Himpens JM, Shikora SA, et al. The first consensus statement on revisional bariatric surgery using a modified Delphi approach. Surg Endosc. Apr 2020; 34(4): 1648-1657. PMID 31218425
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Coding Section

Codes	Number	Description
CPT	43644	Laparoscopy, surgical, gastric restrictive procedurel with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less)
	43645	with gastric bypass and small intestine reconstruction to limit absorption
	43770-43774; 43886-43888	Laparoscopic placement of adjustable gastric restrictive device and laparoscopic and open revision/removal code ranges
	43775	Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (i.e., sleeve gastrectomy)
	43842	Gastric restrictive procedure without gastric bypass, for morbid obesity; vertical-banded gastroplasty
	43843	; other than vertical-banded gastroplasty
	43845	Gastric restrictive procedure with partial gstrectomy, pyloruspreserving duodenoileostomy (50 – 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)
	43846-43847	Gastric restrictive procedure with gastric bypass code range
	43848	Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)
ICD-9 Procedure	43.7	Partial gastrectomy with anastomosis to jejunum (biliopancreatic diversion)
	43.89	Other partial gastrectomy (biliopancreatic diversion with duodenal switch and sleeve gastrectomy)
	44.31	High gastric bypass
	44.68	laparoscopic gastroplasty
	44.69	Other repair of stomach
	44.95-44.98	laparoscopic gastric restrictive procedure (adjustable gastric band and port) code range
ICD-9 Diagnosis	278.01	Morbid obesity
	539.01-539.09	Complications of bariatric procedures, code range
	539.81-539.89	Compolications of other bariatric procedure, code range
	564.2-564.4	Functional digestive disorders following gastrointestinal surgery, code range
	579.3	other and unspecified postsurgical nonabsorption
HCPCS
ICD-10-CM (effective 10/01/15)	E66.01	Morbid obesity
	E66.2	Morbid obesity with alveolar hypoventilation
	K91.01-K91.3	Postprocedural complications and disorders of digestive system, code range
	K95.01, K95.09	Complications of gastric band procedure, code range
	K95.81, K95.89	Complications of other bariatric procedure, code range
ICD-10-PSC (effective 10/01/15)	0D160ZA,0D164ZA, 0D168ZA	Surgical, gastrointestinal system, bypass, stomach, no device, jejunum, code by approach
	0DB60ZZ, 0DB63ZZ, 0DB64ZZ, 0DB67ZZ, 0DB68ZZ	Surgical, gastrointestinal system, excision, stomach, code by approach
	0DP643Z, 0DP64CZ	Surgical, gastrointestinal system, removal, stomach, open, code by device (extraluminal device or intraluminal device)
	0DQ64ZZ	Surgical, gastrointestinal system, repair, stomach, percutaneous endoscopic approach
	0DV60CZ, 0DV60DZ, 0DV60ZZ	Surgical, gastrointestinal system, restriction, stomach, open, code by device (extraluminal device, intraluminal device or no device)
	0DV63CZ, 0DV63DZ, 0DV63ZZ	Surgical, gastrointestinal system, restriction, stomach, percutaneous, code by device (extraluminal device, intraluminal device or no device)
	0DV64CZ, 0DV64DZ, 0DV64ZZ	Surgical, gastrointestinal system, restriction, stomach, percutaneous endoscopic, code by device (extraluminal device, intraluminal device or no device)
	DW64CZ	Sugical, gastrointestinal system, revision, stomach, percutaneous endoscopic, extraluminal device
Type of Service	Surgery
Place of Service	Inpatient

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward     

02/02/2023	Interim review, no change to policy intented. Updating description, background and rationale.
01/09/2023	Annual review, no change to policy intent. Updating guidelines to remove requirement of 7-10% weight loss during the 4-6 months prior to surgery.
12/14/2022	Annual review, no change to policy intent. Updating rationale and references.
03/30/2022	Interim Review. Updating policy verbiage. Also updating rationale and reference.
12/13/2021	Annual review, no change to policy intent, but, guideline update related to adolescent bariatric surgery made. Also updating rationale and references.
12/02/2020	Annual review, no change to policy intent. Updating rationale and references.
12/16/2019	Annual review, no change to policy intent. UPdating description, regulatory status, guidelines, rationale and references.
01/03/2019	Annual review, no change to policy intent.
01/23/2018	Annual review, rewriting the investigational statement on endoscopic procedures for clarity, also adding aspiration therapy device to the investigational statement. Adding a statement regarding the investigational status of surgical treatment of preadolescent children. Updating background, description, guidelines, regulatory status, rationale and references.
12/01/2016	Annual review, adding Single anastomosis duodenoileal bypass with sleeve gastectomy as investigational. Updating background, description, guidelines, rationale and references.
12/15/2015	Annual review, no change to policy intent.
10/28/2014	Annual review. Laparoscopic gastric plication added as investigational. Statement added related to the repair of incidentally identified hiatal hernias. Changed bariatric surgery on members with BMI < 35 from investigational to not medically necessary. Added coding. Updated background, description, guidelines, rationale and references.
09/11/2014	Added disclaimer note regarding need to review plan document for benefits. No change to policy intent.