Surgery Section - Bariatric Surgery

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Morbid obesity is defined as a body mass index (BMI) >40 kg/m2 (normal BMI range: 19-25 kg/m2).  

(Note: BMI may be calculated by using the BMI calculator.)

Individuals with morbid obesity are at high risk for developing weight-related complications such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (colon, prostate, breast, uterus, and ovaries).  In addition, morbid obesity is associated with a shortened life span. ^[1]

The first-line treatment of morbid obesity involves dietary and lifestyle changes. Although this strategy may be effective in some patients, a majority of morbidly obese patients do not achieve significant weight loss through lifestyle modifications. In addition, the weight loss may not be durable, as only a small number of patients are able to comply with the changes on a long-term basis. When conservative measures fail, some patients may consider surgery for morbid obesity (bariatric surgery). 

Several bariatric procedures have been developed, but based on the underlying mechanism of weight loss, all fall into one or both of the following categories:

Restrictive procedures

• Decrease the size of the stomach and limit food intake

Malabsorptive procedures

• Limit the absorption of calories and nutrients by altering the way food moves through the intestinal track
• Multiple variants exist, differing in the reconfiguration of the small intestines and consequently the extent of malabsorption.

The following table briefly summarizes different bariatric procedures:

POLICY CRITERIA

POSITION STATEMENT

• Roux-en-Y Gastric Bypass (RYGBP)
  The Roux-en-Y gastric bypass (RYGBP) is currently considered the gold standard for weight loss surgery and is the most commonly performed bariatric procedure in the United States. It is considered to have the most favorable benefit/risk ratio of all bariatric procedures, and it consistently achieves greater amounts of weight loss compared to alternative procedures, without demonstrable increases in morbidity or mortality. ^[2]
  
  Consequently, in order to determine the safety and efficacy of other bariatric surgical procedures, they need to be compared to RYGB in well-designed, well-executed randomized controlled trials (RCT). 

• Laparoscopic Adjustable Gastric Banding (LAGB)
  
  RCT data comparing the two procedures are limited, however::
• LAGB is reversible and the least invasive of all bariatric procedures.
• Weight loss following LAGB is less than what is usually seen following RYGB.
• LAGB has low perioperative complications, however inadequate weight loss or long term complications of band erosion, slippage, or malfunction may require additional surgery. 

• Other Bariatric Surgical Procedures
  
  The evidence is insufficient to determine the long term safety and efficacy of bariatric surgery procedures other than the RYGB or LAGB.
  
  Non-randomized studies
  Although the published, peer-reviewed literature on non-RYGBP bariatric procedures is voluminous, it consists mostly of case series and retrospective, non-randomized comparisons. Evidence from these studies is unreliable due to inherent design flaws, such as non-random allocation of treatment, lack of appropriate comparison groups, and short-term follow-up. In addition, the inconsistent reporting of weight loss, resolution of comorbidities, adverse events, morbidity, and reoperation rates further limit meaningful comparisons across these studies.
  
  Randomized Controlled Trials
  Very few randomized controlled trials compared other bariatric procedures with RYBP. Overall, the trials were of poor quality and the findings unreliable due to at least one of the following design flaws:
  
  • The trials had very small study populations, limiting the ability to rule out the role of chance as an explanation of findings.
  • The randomization scheme was either inadequate or not explained. Inadequate randomization of study participants may result in unequal distribution of potential confounders, such as clinical characteristics, which in turn may affect the outcome.
  • The studies have short follow-up times so there is no long-term (5-10 years or longer) evidence regarding:
    • durability of weight loss
    • complications (e.g. metabolic side effects, nutritional deficiencies, anastomotic ulcers, esophagitis, procedure-specific complications such as band erosion)
    • resolution of comorbidities (e.g. diabetes, hypertension, obstructive sleep apnea, increased cholesterol)
    • need for reoperations
  • Short-term complications, adverse events, morbidity, resolution of comorbidities, and reoperation rates are inconsistently reported, limiting conclusions and comparisons across studies.
  • There is limited understanding of appropriate patient selection criteria for each of the non-RYGB bariatric procedures (e.g. superobese patients vs. morbidly obese patients).
• Bariatric Surgery in the Pediatric Population
  
  Overall, there is very little evidence on the role of bariatric surgery in treating morbidly obese pediatric patients. Moreover, the evidence mostly comes from small, non-randomized and therefore unreliable studies. Specifically:
  
  
• There is limited evidence that bariatric surgery leads to clinically significant, long-term sustained weight loss and resolution of obesity-related comorbidities in the pediatric population.
• The evidence does not permit conclusions regarding morbidity associated with and safety of any bariatric procedure in the pediatric population.
• There is no evidence regarding the long-term potential impact of bariatric procedures on growth and development in the pediatric population.

• Bariatric Surgery as a treatment for Gastroesophageal reflux Disease (GERD)
  
  In order to determine the safety and efficacy of bariatric surgical procedures as treatments for GERD, they need to be compared to standard medical or surgical treatments of this condition in well-designed, well-executed randomized controlled trials. However, there are no published studies of this nature. In addition, there are no published evidence-based clinical practice guidelines that recommend any bariatric surgical procedure as a treatment of GERD.
  
  
• Endoscopic Bariatric Procedures
  
  There is insufficient evidence to determine the safety and efficacy of any endoluminal procedure as either a primary bariatric procedure or a revision procedure.  The published evidence is very limited and consists of only a few case series and one unreliable randomized trial.
  
  
• Multidisciplinary approach to the clinical management of bariatric surgery patients

The National Institutes of Health/National Heart, Lung, and Blood Institute (NIH/NHLBI) clinical practice guidelines state the importance of a multidisciplinary approach to the clinical management of bariatric surgery patients. Comprehensive programs should address nursing, nutrition, exercise, behavior modification, and psychological support, and they should provide lifelong follow-up for treated patients. ^[1]

• Bariatric Surgery Centers of Excellence

The published evidence indicates that high volume bariatric centers are more likely to be successful in achieving optimal outcomes and lower complication and mortality rates than low volume bariatric centers. ^[3-5] These data have lead to national efforts to establish bariatric surgery centers of excellence by the American Society for Metabolic and Bariatric Surgery, the American College of Surgeons, and the BlueCross BlueShield Association.

Effectiveness

The following effectiveness review of bariatric surgical procedures is based on randomized controlled trials (RCT), Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessments, Cochrane reviews,  and evidence-based guidelines. The non-randomized studies (e.g. case reports, case series, retrospective reviews) are not included in the review as they do not represent the adequate level of evidence due to inherent study design flaws, such as non-random allocation of treatment and lack of appropriate comparison groups.

Distal (Long Limb) Gastric Bypass

TEC Assessment

The 2005 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment identified six comparative trials of long limb gastric bypass with Roux-en-Y anastomosis (LL-RYGB) vs. standard RYGB. ^[2] However, only two were randomized controlled trials (RCT). The assessment determined that there was not sufficient evidence to reach conclusions on the efficacy and safety of LL-RYGB compared to standard RYGB:

• In both RCTs, there was no significant difference in weight loss between the two groups at 1 year.
• The evidence for the super obese (BMI ≥50 kg/m2) population was weak and did not allow conclusions concerning whether LL-GBRY is superior in this subgroup of patients
• The adverse events were poorly reported in all comparative studies. Some of the reports contradicted one another.
• There was no definite cut-off for “long” vs. “standard” limb, making comparisons even more challenging.

Randomized Clinical Trials (RCT)

One RCT evaluated the effectiveness of the distal gastric bypass for weight loss and control of comorbidities ^[6]. The study included only super obese patients (BMI ≥50 kg/m2). There was no significant difference in the control or improvement of hypertension, sleep apnea, or gastroesophageal reflux disorder between the patients who underwent long-limb (Roux limb = 250 cm) and short-limb gastric bypass (Roux limb = 150 cm). In addition, there was no difference in excess weight loss between the groups. Although the study reports better control of lipid disorders and diabetes in patients who underwent the long-limb gastric bypass, several design flaws undermine the reliability of the study findings:

• The small study population (n=105) limits the ability to rule out the role of chance as an explanation of findings.
• The randomization scheme was not explained. Inadequate randomization of study participants may result in unequal distribution of potential confounders, such as clinical characteristics.
• The short-term follow-up limits conclusions regarding the long-term complications and the effectiveness of the distal gastric bypass in controlling weight loss and comorbidities.
• The study included only super obese patients limiting the generalizability of the study findings to other patient populations (i.e. morbidly obese).
• The need for nutritional supplementation after the surgery was reported for the two treatment groups, but there was a failure to include statistical testing for this outcome.

Other comparative studies and case series

A number of non-randomized studies (retrospective comparisons, case series) describe the experiences of patients undergoing distal gastric bypass. ^[2,7-9] As noted at the beginning of the position statement, evidence from these studies is unreliable.

Biliopancreatic Bypass and Biliopancreatic Bypass with Duodenal Switch

TEC Assessment

The 2005 BCBSA TEC Assessment identified only one comparative trial that compared RYGB with biliopancreatic diversion with duodenal switch (BPD-DS). ^[2] Although the trial included 237 RYGB and 113 BPD-DS patients, it was not a randomized clinical study (the choice of the surgery was determined by surgeon and/or patient) and it followed participants for only one year. The TEC Assessment did not find this data sufficient to determine the risk/benefit ratio for this procedure or that it results in greater weight loss than RYGB:

• The % estimated weight loss (EWL) at one year was the same for both the RYGB and BPD-DS groups.
• Data on short-term adverse events was limited, except for the mortality and wound infection rates which were equivalent in both groups.
• More anastomotic leaks were reported in BPD-DS group.
• Long-term complications were not reported.
• Nutritional concerns were not adequately addressed. This is of concern because BPD-DS further reduces fat absorption, affecting the absorption of fat soluble vitamins.

Randomized Controlled Trials (RCT)

Two prospective trials compared the experiences of obese patients undergoing RYGB vs. BPD.

The first trial compared weight loss, metabolic deficiencies, and resolution of comorbidities in morbidly obese patients undergoing RYGB vs. a variant of BPD (BPD with RYGB). ^[10] The study reports comparable nutritional deficiencies between the two procedures. Although better weight loss and resolution of diabetes and hypercholesterolemia was reported in the BPD group, several design flaws undermine the reliability of the study findings:

• The study employed an inadequate randomization scheme: the report states that patients were chosen to undergo RYGB or BPD, but fails to provide any further explanation of how the treatment was assigned. Inadequate randomization of study participants may result in unequal distribution of potential confounders, such as clinical characteristics.
• The RYGB group had a significantly higher level of preexisting comorbidities (p = 0.01), suggesting a difference between the treatment groups that may have affected the outcome.
• The small study population (65 patients/surgery group) limits the ability to rule out the role of chance as an explanation of findings.
• The short-term follow-up (2 years) limits conclusions regarding the long-term metabolic complications and the long-term effectiveness of the BPD in controlling weight loss and comorbidities.

Another small randomized trial (n=60) compared laparoscopic RYGB and BPD-DS for superobese patients (BMI 50-60 kg/m2). ^[11] The study found comparable 30-day perioperative safety and greater weight loss following BPD-DS in the first year. However, several design flaws undermine the reliability of the study findings:

• It is not certain from the data presented whether the study was adequately powered to reliably observe the treatment differences, especially in the stratified sub-analyses.
• The short-term follow-up (one year) limits comparisons regarding the long-term complication rates and the long-term effectiveness of the two procedures in controlling weight loss.
• The effectiveness of the procedures in controlling comorbidites was not compared in this study.

Other comparative studies and case series

A number of non-randomized studies (retrospective comparisons, case series) describe the experiences of patients undergoing biliopancreatic diversion with or without duodenal switch. ^[12-30] As noted at the beginning of the position statement, evidence from these studies is unreliable.

Sleeve Gastrectomy

Cochrane Review

The 2009 Cochrane review of bariatric surgery identified only one randomized controlled trial that compared sleeve gastrectomy to gastric bypass with Roux-en-Y anastomosis (RYGB). ^[31] This very small (n=32) and short trial that followed participants for only 1 year reported that:

• Weight loss and BMI were similar between the two procedures, but % excess weight loss was greater with sleeve gastrectomy.
• Two patients had diabetes at baseline, both in RYGB group. The condition was resolved at 1 year in both patients.  The outcome of other comorbidities reported at baseline was not reported for RYGB or SG groups.  
• Although the study reported no conversions to open surgery and no intraoperative and postoperative complications, the other complications and additional operative procedures were not reported.
• The study did not assess a two-stage approach using sleeve gastrectomy prior to another bariatric procedure and consequently no conclusions about the two-stage approach could be made.
• The short duration of the follow-up results in underestimation of the impact of late complications and the need for revisional surgery.

Randomized Clinical Trials (RCT)

One RCT compared the patients who underwent sleeve gastrectomy (SLG) and standard RYGB surgery. The goal of this study was to compare the effect of the RYGB and SLG on glycemic control. ^[32] It was noted that body weight and BMI decreased markedly and comparably after either procedure. Although the study found that both procedures markedly improved glucose homeostasis (no significant difference was found in insulin and GLP-1 secretion between the two procedures at three months), two major design flaws undermine the reliability of the study findings:

• The very small study population (n=27) limits the ability to rule out the role of chance as an explanation of findings.
• The very short duration of follow-up (3 months) limits conclusions regarding the medium- and long-term impact on glucose metabolism.

Other comparative studies and case series

A number of non-randomized studies (retrospective comparisons, case series) describe the experiences of patients undergoing sleeve gastrectomy. ^[33-52] As noted at the beginning of the position statement, evidence from these studies is unreliable.

Adjustable Gastric Banding

BCBSA TEC Assessment

Although the 2007 Blue Cross Blue Shield TEC Assessment identified eight comparative trials of gastric bypass with Roux-en-Y anastomosis (RYGB) vs. laparoscopic adjustable gastric banding (LAGB), none of the trials was a randomized controlled design that directly compared the two procedures. ^[53] Three trials matched patients on key clinical characteristics, and the rest were comparisons of outcomes from separate clinical series of patients who had RYGB or LAGB.

The assessment of the comparative trials found that there was a tradeoff in terms of safety and efficacy when comparing LAGB and RYGB:

• LAGB was less invasive, required a shorter hospital stay, and was reversible.
• Short-term complications of LAGB were very low and mortality exceedingly rare.
• Weight loss for LAGB at one year was substantial, but inferior to RYGB. The data on the longer-term weight loss was limited and the conclusions less definitive.
• The data on the longer-term complications was inadequate, but it suggested that a considerable minority of the LAGB patients may require reoperations and/or removal of the band.

Cochrane Review

The 2009 Cochrane review of bariatric surgery identified only one randomized controlled trial that compared laparoscopic adjustable gastric banding (LAGB) to laparoscopic gastric bypass with Roux-en-Y anastomosis (RYGB). ^[31] Both procedures were performed laparoscopically. This very small trial (n=51) that followed participants for five years reported that:

• RYGB was superior to LAGB on more than one measure of weight loss (% excess weight loss, mean BMI)
• Early complications requiring reoperation were more present in the RYGB patients, but numbers were small and no tests of statistical significance were reported.
• Comorbidities and late complications were comparable but the numbers were very small and no tests of statistical significance were reported.

Randomized Controlled Trials (RCT)

An updated literature search failed to identify any additional randomized controlled trials that compare LAGB with RYGB.

Other comparative studies and case series

A number of non-randomized studies (retrospective comparisons, case series) describe the experiences of patients undergoing LAGB. ^{[50,53,54-59]} As noted at the beginning of the position statement, evidence from these studies is unreliable.

Mini-Gastric Bypass

Randomized Controlled Trials (RCT)

One small RCT compared the safety and effectiveness of laparoscopic RYGB and mini-gastric bypass (MGBP). ^[60] The study found a comparable rate of late complications (>30 days post-op), weight loss, and comorbidity resolution. MGBP was associated with fewer early complications (<30 days post-op). However, the following design flaws undermine reliability of the study findings:

• The small study population (n=80) limits the ability to rule out the role of chance as an explanation of findings.
• Short-term follow-up (2 years) limits comparisons regarding the longer-term complications rates and the effectiveness of the two procedures in controlling weight loss and comorbidities

Other comparative studies and case series

Several non-randomized studies (retrospective comparisons, case series) describe experiences of patients undergoing MGBP. ^[61-65] As noted at the beginning of the position statement, evidence from these studies is unreliable.

Vertical Banded Gastroplasty (VBG)

VBG has largely been abandoned in the United States due to insufficient weight loss and high reoperation rates (approximately 30%). ^[31]

Endoscopic (Endoluminal) Bariatric Procedures

Randomized Controlled Trials (RCT)

A small randomized trial compared the safety and efficacy of the transabdominal circular stapler (CEEA®) and transoral circular stapler (SurgASSIST®) for performing the gastrojejunostomy in laparoscopic RYGB. ^[66] The study did not find a significant difference between the two procedures on any of the measures except the rate of port site wound infection, suggesting a benefit of the transoral approach. However, several design flaws undermine the reliability of the study findings:

• The very small study population (n=20) limits the ability to rule out the role of chance as an explanation of findings.
• Short-term follow-up (one year) limits comparisons regarding the longer-term safety and effectiveness of the two procedures in controlling the weight loss and comorbidities.
• The randomization scheme was not explained. Inadequate randomization of study participants may result in unequal distribution of potential confounders, such as clinical characteristics, which in turn may affect the study outcome.

Other comparative studies and case series

A small number of non-randomized studies, primarily case series, describe experiences of patients undergoing different endoluminal procedures. ^[67-74]. As noted at the beginning of the position statement, evidence from these studies is unreliable.

Pediatric Bariatric Surgery

Washington State Health Technology Assessment

The 2007 Washington State Health Technology Assessment evaluated the published, peer reviewed scientific literature describing bariatric surgery in the pediatric population. ^[75] Data from 17 studies that enrolled a total of 553 pediatric patients were included. Only one study was clearly prospective. Eight studies reported outcomes after LAGB, six after RYGB, two after VBG, and one after banded bypass. The report concluded that:

• The evidence that LAGB for morbidly obese pediatric patients leads to sustained and clinically significant weight loss compared to non-operative approaches was weak at the longest follow-up after surgery (1.7 to 3.3 years).
• The evidence that RYGB for morbidly obese pediatric patients leads to sustained and clinically significant weight loss compared to non-operative approaches was weak at the longest follow-up after surgery (1 to 6.3 years).
• The evidence was insufficient to permit quantitative estimates of the precise amount of weight loss after any bariatric surgical procedure for pediatric patients.
• The evidence was insufficient to permit any conclusions about weight loss after other bariatric surgical procedures for pediatric patients.
• The evidence was insufficient to permit any conclusions about weight loss in specific age subgroups (18-21, 13-17, 12 or less) within the pediatric population.
• The evidence that LAGB for morbidly obese pediatric patients does resolve comorbid conditions linked to obesity (diabetes, hypertension) compared to non-operative approaches was weak.
• The evidence that RYGB for morbidly obese pediatric patients does resolve comorbid conditions linked to obesity (diabetes, hypertension) compared to non-operative approaches was weak.
• The evidence was insufficient to permit quantitative estimates of the likelihood of comorbidity resolution, quality of life improvement, or survival after any bariatric surgical procedure for pediatric patients.
• The evidence was insufficient to permit any conclusions about comorbidity resolution in specific age subgroups (18-21, 13-17, 12 or less) within the pediatric population.
• The LAGB studies reported no in-hospital or postoperative death. However, the most commonly reported complication was band slippage. Reoperations were performed on 7.9% of the LAGB patients to correct various complications (band slippage, intragastric migration, port/tubing problems).
• The RYGB studies reported one postoperative death. The most frequently reported complication was related to malnutrition and micronutrient deficiency. In addition, potentially life threatening complications (shock, pulmonary embolism, severe malnutrition, bleeding, gastrointestinal obstructions) were reported.
• The evidence was insufficient to permit any conclusions on potential impacts of bariatric surgery on growth and development of pediatric patients.
• The evidence was insufficient to permit any conclusions on potential harms in specific age groups (18-21, 13-17, 12 or less).

In summary, the assessment found that longer term, prospective collection of data on physical growth, quality of life, weight loss, persistence or resolution of comorbid conditions, and long-term survival are needed in order to fully understand the role of bariatric surgical procedures in treating morbidly obese pediatric patients.

RCT

No RCT evaluated the safety and effectiveness of either RYGB or LAGB compared to non-surgical approaches in the pediatric population. In addition, no RCT compared the safety and effectiveness of RYGB compared to LAGB in the pediatric population.

Other comparative studies and case series

Studies with short follow-up time

A small number of non-randomized comparative studies reported significant weight loss and resolution of some of the comorbidities in pediatric patients undergoing bariatric surgery. ^[76-78] However, the studies were small and had a very short follow up time.

Studies with mid-term follow-up time

Two observational studies with mid-term follow-up times (≤10 and ≤8 years) reported experiences of pediatric patients undergoing LAGB (sample size 41and 107 respectively). ^[79,80] The first study found that weight loss was initially successful and resulted in resolution of some comorbidities, but it slowly increased over the time and ultimately was unsatisfactory in many patients. The second study reported 65.5% excess weight loss at eight years. Both studies reported high complication and reoperation rates (Lanthaler: 46% patients had complications that required reoperation; Mittermaier: 46% patients had complications and 29% required reoperation).

However, as noted at the beginning of the position statement, evidence from these studies is unreliable.

Evidence-based Guidelines for Pediatric Bariatric Surgery

The 2005 American College of Physicians evidence-based guideline on use of bariatric surgery in adolescents and children states that the current evidence on surgical treatment of pediatric population is limited to a few case series which do not permit quantitative analysis. Further, the guideline states that it is unclear whether extrapolation of adult data for bariatric surgery to the pediatric population is appropriate and that RCTs are needed (and feasible) to establish the role of bariatric surgery in this population. ^[81]

GERD

RCT

No randomized controlled trials compared standard medical or surgical treatments of GERD with bariatric surgical procedures as a treatment of GERD.

Other comparative studies and case series

One retrospective study compared the in-hospital outcomes of morbidly obese patients who underwent laparoscopic fundoplication for the treatment of GERD versus laparoscopic gastric bypass for the treatment of morbid obesity and related conditions, including GERD. ^[82] As noted at the beginning of the position statement, evidence from these studies is unreliable.

Safety

General Surgical Risks

Bariatric procedures are associated with all the potential risks of any major abdominal surgical procedure including but not limited to:

• Bleeding
• Death
• Infection
• Injury to internal organs or gastrointestinal tract
• Thromboembolic complications

Procedure-specific Surgical Risks

The following table summarizes the most common procedure-specific risks. However, other adverse events are also possible.

References

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Cross References

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Regence Consumer Tx: Weight loss (Bariatric) Surgery

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