Coverage Policy Manual
Policy #: 1998118
Category: Surgery
Initiated: May 1998
Last Review: March 2022
  Surgery for Morbid Obesity

Description:
Surgery for morbid obesity, termed bariatric surgery, falls into two general categories: 1) gastric-restrictive procedures that create a small gastric pouch, resulting in weight loss by producing early satiety and thus decreasing dietary intake; and 2) malabsorptive procedures, which produce weight loss due to malabsorption by altering the normal transit of ingested food through the gastrointestinal tract. Some bariatric procedures may include both a restrictive and a malabsorptive component.
 
Bariatric surgery is performed for the treatment of 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, cardiopulmonary conditions 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, rectum, and prostate; for women: breast, uterus, and ovaries), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 years less 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. The majority of 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 (NIH) 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. (*See Policy Guidelines on how to calculate BMI.)
 
Resolution (cure) or improvement of type 2 diabetes mellitus 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 type 2 diabetes. The various surgical procedures have different effects, and gastrointestinal rearrangement seems to confer additional anti-diabetic benefits independent of weight loss and caloric restriction. The precise mechanisms are not clear, and multiple mechanisms may be involved. Gastrointestinal peptides, 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.
 
The following summarizes the different restrictive and malabsorptive procedures.
 
Gastric Restrictive Procedures
 
1. Vertical-Banded Gastroplasty (CPT code 43842)
 
Vertical-banded gastroplasty was formerly one of the most common gastric restrictive procedures performed in this country but has more recently declined in popularity. 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 two requiring reoperation. Dilation of the stoma is a common reason for weight regain. Vertical-banded gastroplasty may be performed using an open or laparoscopic approach.
 
2. Adjustable Gastric Banding (CPT code 43770—laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device [e.g., gastric band and subcutaneous port components])
 
Adjustable gastric banding involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir that is 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; currently, one such device is approved by the U.S. Food and Drug Administration (FDA) for marketing in the U.S., Lap-Band (BioEnterics, Carpinteria, CA). 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 lbs 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."
 
A second adjustable gastric banding device was approved by the FDA through the Premarket Approval (PMA) process in September 2007, the REALIZE® model (Ethicon Endo-Surgery, Cincinnati, OH). Labeled indications for this device are as listed below:
 
“The [REALIZE] device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a BMI 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.”
 
3. Open Gastric Bypass (CPT code 43846—gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb [150 cm or less] Roux-en-Y gastroenterostomy)
 
The original gastric bypass surgeries were based on the observation that post-gastrectomy patients tended to lose weight. The current procedure 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.” Operative complications include leakage and marginal ulceration at the anastomotic site. Because the normal flow of food is disrupted, there are more metabolic complications compared to other gastric restrictive procedures, including iron deficiency anemia, vitamin B-12 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 to 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.
 
4. Laparoscopic Gastric Bypass (CPT code 43644—laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy [roux limb 150 cm or less])
 
CPT code 43644 was introduced in 2005 and essentially described the same procedure as No. 3, but performed laparoscopically.
 
5. Mini-Gastric Bypass (no specific CPT code)
 
Recently, a variant of the gastric bypass, called the mini-gastric bypass, has been popularized. Using a laparoscopic approach, the stomach is segmented, similar to a traditional gastric bypass, but instead of creating a Roux-en-Y anastomosis, the jejunum is anastomosed directly to the stomach, similar to a Billroth II procedure. This unique aspect of this procedure is not based on its laparoscopic approach but rather the type of anastomosis used. It should also be noted that CPT code 43846 explicitly describes a Roux-en-Y gastroenterostomy, which is not used in the mini-gastric bypass.
 
6. Sleeve gastrectomy (CPT code 43775 – laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy [i.e., sleeve gastrectomy])
 
A sleeve gastrectomy is an alternative approach to gastrectomy that can be performed on its own or in combination with malabsorptive procedures (most commonly biliopancreatic diversion 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) that is 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 two-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, such as biliopancreatic diversion.
 
Endoluminal (also called endosurgical, endoscopic, or natural orifice) bariatric procedures
 
With these procedures access to the relevant anatomical structures is gained through the mouth without skin incisions. Primary and revision bariatric procedures are being developed to reduce the risks associated with open and laparoscopic interventions. Examples of endoluminal bariatric procedures studies include gastroplasty using a transoral endoscopically guided stapler and placement of devices such as a duodenal-jejunal sleeve and gastric balloon.
 
Malabsorptive Procedures
 
The multiple variants of malabsorptive procedures differ in the lengths of the alimentary limb, the biliopancreatic limb, and the common limb, in which the alimentary and biliopancreatic limbs are anastomosed. These procedures also may include an element of a restrictive surgery based on the size of the stomach pouch. The degree of malabsorption is related to the length of the alimentary and common limbs. For example, a shorter alimentary limb (i.e., the greater the amount of intestine that is excluded from the nutrient flow) will be associated with malabsorption of a variety of nutrients, while a short common limb (i.e., the biliopancreatic juices are allowed to mix with nutrients for only a short segment) will primarily limit absorption of fat.
 
1. Biliopancreatic Bypass Procedure(also known as the Scopinaro procedure) (CPT code 43847— gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption)
 
Biliopancreatic bypass (BPB) procedure, developed and used extensively in Italy, was designed to address some of the drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many of the complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPB 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.
 
    • A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.
    • A 200 cm long “alimentary tract” consists of 200cm of ileum connecting the stomach to a common distal segment.
    • A 300-400 cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.
    • A 50-100 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.
    • Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.
 
Many potential metabolic complications are related to biliopancreatic bypass, including most prominently iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. In addition, there have been several case reports of liver failure resulting in death or liver transplant.
 
2. Biliopancreatic Bypass with Duodenal Switch (CPT code 43845—gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy [50 to 100 cm common channel] to limit absorption [biliopancreatic diversion with duodenal switch])
 
CPT code 43845, which specifically identifies the duodenal switch procedure, was introduced in 2005. The duodenal switch procedure is essentially a variant of the biliopancreatic bypass described above. 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 biliopancreatic bypass, 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 biliopancreatic bypass, i.e., producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.
 
3. Long-Limb Gastric Bypass (i.e., >150 cm) (CPT code 43847—Gastric restrictive procedure with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption)
 
Recently, variations of gastric bypass procedures have been described, consisting primarily of long-limb Roux-en-Y procedures, 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, i.e., either by resection or stapling along the horizontal or vertical axis. Unlike the traditional gastric bypass, which is essentially 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.
 
4. Laparoscopic Malabsorptive Procedure (CPT code 43645—Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption)
 
CPT code 43645 was introduced in 2005 to specifically describe a laparoscopic malabsorptive procedure. However, the  not specifically describe any specific malabsorptive procedure.
 

Policy/
Coverage:
Bariatric surgery has contract limitations or is a contract exclusion in some member benefit certificates of coverage. The following Policy/Coverage statements apply to those members with contracts without these limitations and exclusions.
 
Note:  This policy does not apply to members of the JB Hunt Plan. Please refer to the JB Hunt Transport Services, Inc. Summary Plan Document for specific benefit criteria for bariatric surgery.
 
Note:  For ASE/PSE members, there is no coverage for bariatric procedures except for those members enrolled in the Bariatric Pilot Program. During time-periods when the enrollment into the Bariatric Pilot Program, is suspended, non-coverage of bariatric surgery services for ASE/PSE members is based on an exclusion in the Summary Plan Description (SPD).
 
Note:  For members of the Arkansas Blue Cross Blue Shield Health Advantage Self-Insured, Employee Group, please refer to the member’s Summary Plan Description for requirements and eligibility criteria for services related to bariatric surgery.
 
Effective August 2021
 
Any devices used for bariatric surgery must be used in accordance with the U.S. Food and Drug Administration (FDA) approved indications.
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Roux-en Y gastroenterostomy, sleeve gastrectomy or LAP-BAND or Realize adjustable gastric banding, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when ALL of the following criteria are met:
 
    • Patients with morbid obesity with a Body Mass Index (BMI) greater than or equal to 40; AND  
    • Have failed a structured weight loss or diet program in the 2 years preceding the request for surgical treatment of morbid obesity
    • Must have completed one structured weight loss or diet program for 6 consecutive months or two for 3 consecutive months AND
    • The weight loss or diet program may be either a medical program or a commonly available program (e.g., including but not limited to Weight Watchers, Jenny Craig or Metabolic Research Center); AND
    • Are well-motivated and understand the risks of the surgery and the restricted eating habits which follow the gastric restrictive or bypass surgery; AND  
    • Are over the age of 20.
 
Roux-en Y gastroenterostomy, sleeve gastrectomy or LAP-BAND or Realize adjustable gastric banding, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for adolescents (age 13-20 years) when ALL the following criteria are met:
 
    • BMI of 35 kg/m2 (or 120% of the 95th percentile for age and sex, whichever is lower) with clinically significant disease (e.g., type 2 diabetes mellitus, obstructive sleep apnea, pseudotumor cerebri or any life threatening or serious medical condition that is weight induced), OR  
    • BMI of 40 kg/m2 (or 140% of the 95th percentile for age and sex, whichever is lower) with commonly present though not required comorbidities (e.g., hypertension, dyslipidemias, gastroesophageal reflux); AND
    • Had unsuccessful physician-monitored weight loss attempts for at least 6 months; AND
    • Has achieved 95% or more of his/her adult height by determination of bone age; AND  A psychological assessment to determine decision-making capacity, ability to give informed consent, and willingness to adhere to requirements of postoperative care.     
 
Body Mass Index of 35 – 39
Patients with Body Mass Index of 35 - 39 may be considered for coverage if they meet the other criteria above, and have high-risk co-morbid conditions (e.g., uncontrolled diabetes mellitus, uncontrolled obstructive sleep apnea as defined in the sleep apnea policy, uncontrolled hypertension, uncontrolled hyperlipidemia, pseudotumor cerebri).
 
Biliopancreatic Diversion with Duodenal Switch
 
Biliopancreatic diversion with duodenal switch for treatment of obesity that has not responded to conservative measures meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for members with BMI >/= 50.
 
Concomitant Hiatal Hernia Repair with Bariatric Surgery
 
Repair of a hiatal hernia at the time of bariatric surgery meets member benefit certificate primary coverage criteria for patients who have a pre-operatively diagnosed hiatal hernia with indications for surgical repair.  (Effective November 2014)
 
For members with contracts without a bariatric surgery benefit, if a hiatal hernia repair is done concomitantly with a bariatric procedure, there is no coverage for either procedure (Effective August 2017).
 
ASE/PSE Members
For ASE/PSE members with a health plan that is offered, issued or renewed on or after January 1, 2012, services for bariatric surgery are covered only for those members enrolled in the Bariatric Pilot Program during a time period when the pilot program is open for enrollment. Program requirements and eligibility criteria in the member’s Summary Plan Description (SPD) must be followed. Coverage for bariatric surgery for these members includes:
 
    • Gastric bypass surgery;  
    • Adjustable gastric banding surgery;  
    • Sleeve gastrectomy surgery; and
    • Duodenal switch biliopancreatic diversion.    
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The following procedures do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
 
    • Small bowel bypass procedures as stand-alone procedures
    • Gastric wrapping
    • The Garren-Edwards gastric bubble or any similar device
    • Mini gastric bypass (one anastomosis gastric bypass)
    • Jejunoileal bypass
    • Biliopancreatic bypass without duodenal switch
    • Endoscopic procedures (e.g., insertion of the StomaphyX™ device, AspireAssist, insertion of a gastric balloon, including but not limited to the Obalon Balloon System, Orbera Intragastric Balloon System or the Transpyloric Shuttle, endoscopic gastroplasty, or use of an endoscopically placed duodenal-jejunal sleeve) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
    • Long-limb gastric bypass (greater than 150cm)
    • Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair (Effective November 2014)
    • Laparoscopic gastric plication (Effective November 2014)
    • Vagus (or vagal) nerve blocking devices
    • Single anastomosis duodenoileal bypass with sleeve gastrectomy (Effective March 2016)
    • All other bariatric procedures not listed as covered
 
For members with contracts without primary coverage criteria the following services are considered investigational:
 
    • Small bowel bypass procedures as stand-alone procedures
    • Gastric wrapping
    • The Garren-Edwards gastric bubble or any similar device
    • Mini gastric bypass (one anastomosis gastric bypass)
    • Jejunoileal bypass
    • Biliopancreatic bypass without duodenal switch
    • Endoscopic procedures (e.g., insertion of the StomaphyX™ device, AspireAssist, insertion of a gastric balloon, including but not limited to the Obalon Balloon System, Orbera Intragastric Balloon System or the Transpyloric Shuttle, endoscopic gastroplasty, or use of an endoscopically placed duodenal-jejunal sleeve) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
    • Long-limb gastric bypass (greater than 150cm)
    • Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair (Effective November 2014)
    • Laparoscopic gastric plication (Effective November 2014)
    • Vagus (or vagal) nerve blocking devices
    • Single anastomosis duodenoileal bypass with sleeve gastrectomy (Effective March 2016)
    • All other bariatric procedures not listed as covered
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective March 2021 through July 2021
 
Any devices used for bariatric surgery must be used in accordance with the U.S. Food and Drug Administration (FDA) approved indications.
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Roux-en Y gastroenterostomy, sleeve gastrectomy or LAP-BAND or Realize adjustable gastric banding, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when ALL of the following criteria are met:
 
    • Patients with morbid obesity with a Body Mass Index (BMI) greater than or equal to 40; AND  
    • Have failed a structured weight loss or diet program in the 2 years preceding the request for surgical treatment of morbid obesity
    • Must have completed one structured weight loss or diet program for 6 consecutive months or two for 3 consecutive months AND
    • The weight loss or diet program may be either a medical program or a commonly available program (e.g., including but not limited to Weight Watchers, Jenny Craig or Metabolic Research Center); AND
    • Are well-motivated and understand the risks of the surgery and the restricted eating habits which follow the gastric restrictive or bypass surgery; AND  
    • Are over the age of 20.
 
Roux-en Y gastroenterostomy, sleeve gastrectomy or LAP-BAND or Realize adjustable gastric banding, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for adolescents (age 13-20 years) when ALL the following criteria are met:
 
    • BMI of 35 kg/m2 (or 120% of the 95th percentile for age and sex, whichever is lower) with clinically significant disease (e.g., type 2 diabetes mellitus, obstructive sleep apnea, pseudotumor cerebri or any life threatening or serious medical condition that is weight induced), OR  
    • BMI of 40 kg/m2 (or 140% of the 95th percentile for age and sex, whichever is lower) with commonly present though not required comorbidities (e.g., hypertension, dyslipidemias, gastroesophageal reflux); AND
    • Had unsuccessful physician-monitored weight loss attempts for at least 6 months; AND
    • Has achieved 95% or more of his/her adult height by determination of bone age; AND  A psychological assessment to determine decision-making capacity, ability to give informed consent, and willingness to adhere to requirements of postoperative care.     
 
Body Mass Index of 36 – 39
Patients with Body Mass Index of 36 - 39 may be considered for coverage if they meet the other criteria above, and have high-risk co-morbid conditions (e.g., uncontrolled diabetes mellitus, uncontrolled obstructive sleep apnea as defined in the sleep apnea policy, uncontrolled hypertension, uncontrolled hyperlipidemia).
 
Biliopancreatic Diversion with Duodenal Switch
 
Biliopancreatic diversion with duodenal switch for treatment of obesity that has not responded to conservative measures meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for members with BMI >/= 50.
 
Concomitant Hiatal Hernia Repair with Bariatric Surgery
 
Repair of a hiatal hernia at the time of bariatric surgery meets member benefit certificate primary coverage criteria for patients who have a pre-operatively diagnosed hiatal hernia with indications for surgical repair.  (Effective November 2014)
 
For members with contracts without a bariatric surgery benefit, if a hiatal hernia repair is done concomitantly with a bariatric procedure, there is no coverage for either procedure (Effective August 2017).
 
ASE/PSE Members
For ASE/PSE members with a health plan that is offered, issued or renewed on or after January 1, 2012, services for bariatric surgery are covered only for those members enrolled in the Bariatric Pilot Program during a time period when the pilot program is open for enrollment. Program requirements and eligibility criteria in the member’s Summary Plan Description (SPD) must be followed. Coverage for bariatric surgery for these members includes:
 
    • Gastric bypass surgery;  
    • Adjustable gastric banding surgery;  
    • Sleeve gastrectomy surgery; and
    • Duodenal switch biliopancreatic diversion.    
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The following procedures do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
 
    • Small bowel bypass procedures as stand-alone procedures
    • Gastric wrapping
    • The Garren-Edwards gastric bubble or any similar device
    • Mini gastric bypass
    • Biliopancreatic bypass without duodenal switch
    • Endoscopic procedures (e.g., insertion of the StomaphyX™ device, insertion of a gastric balloon, including but not limited to the Obalon Balloon System, endoscopic gastroplasty, or use of an endoscopically placed duodenal-jejunal sleeve) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
    • Long-limb gastric bypass
    • Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair (Effective November 2014)
    • Laparoscopic gastric plication (Effective November 2014)
    • Single anastomosis duodenoileal bypass with sleeve gastrectomy (Effective March 2016)
    • All other bariatric procedures not listed as covered
 
For members with contracts without primary coverage criteria the following services are considered investigational:
 
    • Small bowel bypass procedures as stand-alone procedures
    • Gastric wrapping
    • The Garren-Edwards gastric bubble or any similar device
    • Mini gastric bypass
    • Biliopancreatic bypass without duodenal switch
    • Endoscopic procedures (e.g., insertion of the StomaphyX™ device, insertion of a gastric balloon, including but not limited to the Obalon Balloon System,  endoscopic gastroplasty, or use of an endoscopically placed duodenal-jejunal sleeve) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
    • Long-limb gastric bypass
    • Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair (Effective November 2014)
    • Laparoscopic gastric plication (Effective November 2014)
    • Single anastomosis duodenoileal bypass with sleeve gastrectomy (Effective March 2016)
    • All other bariatric procedures not listed as covered
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective January 1, 2019 to March 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Roux-en Y gastroenterostomy, sleeve gastrectomy or LAP-BAND or Realize adjustable gastric banding, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when ALL of the following criteria are met:
 
        • Patients with morbid obesity with a Body Mass Index (BMI) greater than or equal to 40; AND  
        • Have failed a structured weight loss or diet program in the 2 years preceding the request for surgical treatment of morbid obesity
        • Must have completed one structured weight loss or diet program for 6 consecutive months or two for 3 consecutive months AND
        • The weight loss or diet program may be either a medical program or a commonly available program (e.g., including but not limited to Weight Watchers, Jenny Craig or Metabolic Research Center); AND
        • Are well-motivated and understand the risks of the surgery and the restricted eating habits which follow the gastric restrictive or bypass surgery; AND  
        • Are over the age of 20.
 
Roux-en Y gastroenterostomy, sleeve gastrectomy or LAP-BAND or Realize adjustable gastric banding, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for adolescents (age 13-20 years) when ALL of the following criteria are met:
 
        • BMI of 40 kg/m2  or more with serious comorbidities (e.g., type 2 diabetes mellitus, obstructive sleep apnea, pseudotumor cerebri or any life threatening or serious medical condition that is weight induced), OR  
        • BMI of 50 kg/m2  or more with less severe comorbidities (e.g., hypertension, dyslipidemias, gastroesophageal reflux); AND
        • Had unsuccessful physician-monitored weight loss attempts for at least 6 months; AND
        • Has achieved 95% or more of his/her adult height by determination of bone age; AND  
        • A psychological assessment to determine decision-making capacity, ability to give informed consent, and willingness to adhere to requirements of postoperative care.  
 
Biliopancreatic Diversion with Duodenal Switch
 
Biliopancreatic diversion with duodenal switch for treatment of obesity that has not responded to conservative measures meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for members with BMI >/= 50.
 
Concomitant Hiatal Hernia Repair with Bariatric Surgery
 
Repair of a hiatal hernia at the time of bariatric surgery meets member benefit certificate primary coverage criteria for patients who have a preoperatively-diagnosed hiatal hernia with indications for surgical repair.  (Effective November 2014)
 
For members with contracts without a bariatric surgery benefit, if a hiatal hernia repair is done concomitantly with a bariatric procedure, there is no coverage for either procedure (Effective August, 2017).
 
Body Mass Index of 36 – 39
 
Patients with Body Mass Index of 36 - 39 may be considered for coverage if they meet the other criteria above, and have high-risk co-morbid conditions (e.g., uncontrolled diabetes mellitus, uncontrolled obstructive sleep apnea as defined in the sleep apnea policy, uncontrolled hypertension, uncontrolled hyperlipidemia).
  
For ASE/PSE members with a health plan that is offered, issued or renewed on or after January 1, 2012, services for bariatric surgery are covered only for those members enrolled in the Bariatric Pilot Program during a time period when the pilot program is open for enrollment. Program requirements and eligibility criteria in the member’s Summary Plan Description (SPD) must be followed. Coverage for bariatric surgery for these members includes:
 
        • Gastric bypass surgery;  
        • Adjustable gastric banding surgery;  
        • Sleeve gastrectomy surgery; and
        • Duodenal switch biliopancreatic diversion.    
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The following procedures do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
        • Small bowel bypass procedures as stand-alone procedures
        • Gastric wrapping
        • The Garren-Edwards gastric bubble or any similar device
        • Mini gastric bypass
        • Biliopancreatic bypass without duodenal switch
        • Endoscopic procedures (e.g., insertion of the StomaphyX™ device, insertion of a gastric balloon, including but not limited to the Obalon Balloon System, endoscopic gastroplasty, or use of an endoscopically placed duodenal-jejeunal sleeve) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
        • Long-limb gastric bypass
        • Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair (Effective November 2014)
        • Laparoscopic gastric plication (Effective November 2014)
        • Single anastomosis duodenolileal bypass with sleeve gastrectomy (Effective March 2016)
        • All other bariatric procedures not listed as covered
 
For members with contracts without primary coverage criteria the following services are considered investigational:
 
        • Small bowel bypass procedures as stand-alone procedures
        • Gastric wrapping
        • The Garren-Edwards gastric bubble or any similar device
        • Mini gastric bypass
        • Biliopancreatic bypass without duodenal switch
        • Endoscopic procedures (e.g., insertion of the StomaphyX™ device, insertion of a gastric balloon, including but not limited to the Obalon Balloon System,  endoscopic gastroplasty, or use of an endoscopically placed duodenal-jejeunal sleeve) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
        • Long-limb gastric bypass
        • Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair (Effective November 2014)
        • Laparoscopic gastric plication (Effective November 2014)
        • Single anastomosis duodenolileal bypass with sleeve gastrectomy (Effective March 2016)
        • All other bariatric procedures not listed as covered
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to January 1, 2019
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Vertical banded gastroplasty, Roux-en Y gastroenterostomy, LAP-BAND or Realize adjustable gastric banding, or sleeve gastrectomy meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when ALL of the following criteria are met:
    • Patients with morbid obesity with a Body Mass Index (BMI) greater than or equal to 40; AND
    • Have failed a structured weight loss program; AND
    • Are well-motivated and understand the risks of the surgery and the restricted eating habits which follow the gastric restrictive or bypass surgery; AND
    • Are over the age of 20.
 
Vertical banded gastroplasty, Roux-en Y gastroenterostomy, LAP-BAND or Realize Adjustable gastric banding, or sleeve gastrectomy meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for adolescents (age 13-20 years) when ALL of the following criteria are met:
    • BMI of 40 kg/m2  or more with serious comorbidities (e.g., type 2 diabetes mellitus, obstructive sleep apnea, pseudotumor cerebri), OR
    • BMI of 50 kg/m2  or more with less severe comorbidities (e.g., hypertension, dyslipidemias, gastroesophageal reflux); AND
    • Had unsuccessful physician-monitored weight loss attempts for at least 6 months; AND
    • Has achieved 95% or more of his/her adult height by determination of bone age; AND
    • A psychological assessment to determine decision-making capacity, ability to give informed consent, and willingness to adhere to requirements of postoperative care.  
 
For ASE/PSE members with a health plan that is offered, issued or renewed on or after January 1, 2012, services for bariatric surgery are covered.  Coverage for bariatric surgery includes:
      • Gastric bypass surgery;
      • Adjustable gastric banding surgery;
      • Sleeve gastrectomy surgery; and
      • Duodenal switch biliopancreatic diversion.
 
Patients with Body Mass Index of 36 - 39 may be considered for coverage if they meet the other criteria above, and have high-risk co-morbid conditions (e.g., uncontrolled  diabetes mellitus, uncontrolled  obstructive sleep apnea as defined in the sleep apnea policy, uncontrolled hypertension, uncontrolled hyperlipidemia).
 
Biliopancreatic diversion with duodenal switch for treatment of obesity that has not responded to conservative measures meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for members with BMI >/= 50.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The following procedures do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
        • Small bowel bypass procedures as stand-alone procedures
        • Gastric wrapping
        • The Garren-Edwards gastric bubble or any similar device
        • Mini gastric bypass
        • Biliopancreatic bypass without duodenal switch
        • Endoscopic procedures (e.g., insertion of the StomaphyX™ device) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
        • Long-limb gastric bypass
 
For members with contracts without primary coverage criteria the following services are considered investigational:
        • Small bowel bypass procedures as stand-alone procedures
        • Gastric wrapping
        • The Garren-Edwards gastric bubble or any similar device
        • Mini gastric bypass
        • Biliopancreatic bypass without duodenal switch
        • Endoscopic procedures (e.g., insertion of the StomaphyX™ device) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks
        • Long-limb gastric bypass
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to December 2011
The following surgical procedures for the treatment of obesity meet primary coverage criteria for effectiveness and are covered when coverage criteria below are met:
    • vertical banded gastroplasty,
    • Roux-en Y gastroenterostomy;
    • LAP-BAND Adjustable Gastric Banding System or Realize Adjustable Gastric Band; or
    • Sleeve gastrectomy
    • Patients with morbid obesity are covered for gastric restrictive or bypass surgery if they:
    • Have a Body Mass Index (BMI) greater than or equal to 40,
    • Have failed a structured weight loss program,
    • Are well-motivated and understand the risks of the surgery and the restricted eating habits which follow the gastric restrictive or bypass surgery, and
    • Are over the age of 20.
 
Covered gastric restrictive or bypass procedures for morbid obesity are covered for adolescents (age 13-20 years) when the individual has:
    • BMI of 40 kg/m2  or more with serious comorbidities (e.g., type 2 diabetes mellitus, obstructive sleep apnea, pseudotumor cerebri), OR
    • BMI of 50 kg/m2  or more with less severe comorbidities (e.g., hypertension, dyslipidemias, gastroesophageal reflux); AND
    • Had unsuccessful physician-monitored weight loss attempts for at least 6 months; AND
    • Has achieved 95% or more of his/her adult height by determination of bone age; AND
    • A psychological assessment to determine decision-making capacity, ability to give informed consent, and willingness to adhere to requirements of postoperative care.   
  
Patients with Body Mass Index of 36 - 39 may be considered for coverage if they meet the other criteria above, and have high-risk co-morbid conditions (e.g., uncontrolled  diabetes mellitus, uncontrolled  obstructive sleep apnea as defined in the sleep apnea policy, uncontrolled hypertension, uncontrolled hyperlipidemia).
 
Biliopancreatic diversion with duodenal switch for treatment of obesity meets primary coverage criteria for effectiveness and is covered for members with BMI >/= 45.
 
Sleeve gastrectomy is covered for members with super-super-obesity (BMI > 60 kg/m2), with severe cardiac or pulmonary comorbidities, that would preclude other surgical procedures for the treatment of morbid obesity.  Sleeve gastrectomy in any other circumstance does not meet member certificate of benefit Primary Coverage Criteria for effectiveness.  There is lack of evidence supporting effectiveness of the procedure in these circumstances or its superiority compared to commonly performed procedures.
 
Sleeve gastrectomy for any indication other than those listed as covered is considered investigational for members with contracts that do not have Primary Coverage Criteria.  Investigational services are an exclusion in the member benefit certificate.  
 
Endoscopic procedures (e.g., insertion of the StomaphyX™ device) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches, as primary surgical treatment for morbid obesity, or to repair gastric leaks do not meet Primary Coverage Criteria for effectiveness.  Member benefit contract Primary Coverage Criteria excludes coverage for services: if there is a lack of scientific evidence regarding a new intervention; if the available scientific evidence is in conflict or the subject of continuing debate; or if  the procedure is the subject of an ongoing phase I, II, or III trial or is otherwise under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis.
 
The following procedures:
    • Small bowel bypass procedures as stand-alone procedures
    • Gastric wrapping
    • The Garren-Edwards gastric bubble or any similar device
    • Mini gastric bypass are not covered  based on benefit certificate primary coverage criteria.
 
For members with  Contracts without primary coverage criteria the following services are considered investigational and are not covered:
    • Small bowel bypass procedures as stand-alone procedures
    • Gastric wrapping
    • The Garren-Edwards gastric bubble or any similar device
    • Mini gastric bypass
    • Endoscopic procedures (e.g., insertion of the StomaphyX device)
Investigational services are an exclusion in the member certificate of coverage.

Rationale:
Definition of Outcomes
Outcomes of bariatric surgeries are notoriously difficult to evaluate due in part to the constantly evolving nature of the surgery. Small modifications are commonly made to decrease the incidence of postoperative and long-term complications. In addition, other than one exception (discussed here), no controlled studies have directly measured the weight loss and complications associated with the different surgical approaches, particularly comparing gastric restrictive procedures with malabsorptive procedures. Case series from individual institutions or individual surgeons with varying lengths of follow-up dominate the literature. The outcomes for specific surgeries may widely differ among institutions or surgeons, perhaps due to small variations in surgical technique, intensity of follow-up, or patient selection criteria. However, during the 1970s and 1980s both vertical-banded gastroplasty (VBG) and gastric bypass became widely accepted types of bariatric surgery. These 2 procedures were the focus of the 1991 NIH Consensus Development Conference on gastrointestinal surgery for severe obesity, which also noted that limited data were available regarding biliopancreatic bypass.   Therefore, vertical-banded gastroplasty and gastric bypass are considered the gold standards for the purpose of this discussion, and the results of these procedures will be compared to the newer procedures not addressed by the 1991 conference;  i.e., gastric banding and biliopancreatic bypass with or without duodenal switch. The following outcomes are considered relevant for bariatric surgery:
 
Weight loss
There is no uniform standard for reporting results of weight loss, and no uniform standard 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 two methods are generally preferred over the absolute amount of weight loss, since 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. The following table summarizes the variation in reporting weight loss outcomes.
Outcome Measure                             Definition                                               Clinical Significance
Decrease in weight                            Absolute difference in weight                   Unclear relationship to outcomes, pre- and post-treatment especially in morbidly obese
Decrease in BMI                                Absolute difference in BMI                       May be clinically significant if change pre- and post-treatment in BME clearly leads to change in risk category
% of excess weight loss                    Amount of weight loss divided                  Has anchor to help frame clinical (%EWL) by excess body weight significance; unclear threshold for clinical significance
% patients. Losing >50% of EBW      No. patients losing >50% EBW                 Additional advantage of framing on per divided by total patients.  Patient basis. Threshold for significance (>50%) arbitrary % ideal body weight Final weight divided by ideal Has anchor to help frame clinical body weight significance; unclear threshold for clinical significance
 
Durability of weight loss
Weight change (i.e., gain or loss) at yearly intervals is often reported. The weight loss with gastric restrictive procedures is thought to be less durable compared to malabsorptive procedures, due to the dilation of the gastric pouch.
 
• Operative and peri-operative complications
There is an increased incidence of operative and peri-operative complications in obese patients in general and particularly in thromboembolism and problems with wound healing.
 
• Reoperation rate
Reoperation may be required to either “take down” or revise the original procedure. Reoperation may be particularly common in vertical-banded gastroplasty due to pouch dilation.
 
• Metabolic side effects
Metabolic side effects are of particular concern in malabsorptive procedures.
 
• Final health outcomes in terms of complications of obesity
Aside from psychosocial concerns, which may be considerable, one of the motivations 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. (See further discussion in summary.)
 
Surgical Procedures
The following discussion provides a representative summary of the literature on bariatric surgery, focusing on improvements in co-morbidities of obesity.
 
Vertical-Banded Gastroplasty
As a representative example of a large case series with long-term follow-up, MacLean and colleagues reported on 201 patients who underwent vertical-banded gastroplasty and who were followed up for a minimum of 2 years.   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 durable weight loss of 75% to 100% of excess weight. The procedure was less successful in the super obese, defined as a BMI of >50 kg/m-2, in whom only 8% achieved an excellent result. These results suggest that failures of vertical-banded gastroplasty are primarily technical in nature. Based on these results, the authors have altered their surgical technique by reinforcing the staple lines to reduce the incidence of perforation. It is this type of small change in surgical technique that can markedly affect results among different surgeons. In a 1987 case series of 305 patients undergoing vertical banded gastroplasty, there was a mean weight loss of 60% of excess weight at 2-year follow-up.   In contrast to MacLean’s report, there was only a 1.3% incidence of staple line disruption. Significant decreases in cardiovascular risk factors and incidence of diabetes and sleep apnea have also been reported.   For example, Melissas and colleagues evaluated obesity’s comorbid conditions in 62 patients who had undergone a vertical-banded gastroplasty.  All patients were followed up for 12 to 48 months, with 84% of patients losing at least 50% of their excess weight. Of the 218 weight-related pathologic conditions existing before the operation, 83% were either cured or improved.
 
Gastric Bypass with Short Limb (<100 cm)
While vertical banded gastroplasty was perhaps the dominant bariatric surgery in the 1980s, it has been surpassed in this country by the gastric bypass procedure, based on a variety of studies that report improved weight loss with a gastric bypass procedure. For example, in 1990, Hall and colleagues reported on the results of a trial that randomized 310 morbidly obese patients to gastric bypass, vertical banded gastroplasty or horizontal gastroplasty. The percent of patients with greater than 50% excess weight loss at 3 years’ follow-up was 67% for gastric bypass, 48% for vertical banded gastroplasty, and 17% for horizontal gastroplasty.
 
Griffen summarized the experience of over 10,000 gastric bypass operations from a number of bariatric surgeons.   It was estimated that 85% of patients reduced their weight to at least 50% above the ideal weight. In about 5,000 patients who were followed up for 10 years, 80% were able to maintain this result. Pories and colleagues reported on 608 patients who underwent a gastric bypass procedure and were followed up for 1–14 years.  One of the unique features of this report is that only 3% of patients were lost to follow-up. The average weight loss was 75% of excess weight at 1 year, declining to 50% by the eighth year. The authors observed an immediate drop in both blood glucose and exogenous insulin requirements after surgery. Long-term observation of 298 patients with preoperative diabetes or impaired glucose intolerance revealed that 91% had normal values for blood glucose and hemoglobin A1C after surgery. The incidence of hypertension declined from 58% before surgery to 14% after gastric bypass. Flickinger and colleagues reported on the incidence of diabetes and hypertension in a case series of 397 patients.  Prior to surgery, 22% had diabetes mellitus and 13% had impaired glucose intolerance. After surgery, all but one of the patients remained euglycemic. A total of 57% of patients were hypertensive before surgery compared to only 18% after surgery. Similarly, Pories and colleagues reported that of 163 obese patients with diabetes or impaired glucose tolerances, only 5% remained with inadequate control after gastric bypass surgery and associated weight loss. Other studies have reported that gastric bypass surgery and weight loss are associated with improvements in the lipid profile.
 
In the 1 controlled trial reported, Sugerman and colleagues randomized 40 patients to receive either a vertical-banded gastroplasty or a gastric bypass procedure.  After 9 months, the gastric bypass patients had significantly greater weight loss that persisted at 3-year follow-up. The gastric bypass patients lost approximately 64% of excess weight, whereas the gastroplasty patients lost only 37% of excess weight. In this study, technical differences could not explain the discrepancy, since small, intact gastric pouches were seen in patients who experienced unsuccessful vertical banded gastroplasty procedures. The authors hypothesized that the unpleasant dumping syndrome, seen most frequently in sweets eaters, may have been responsible for the increased success of the gastric bypass procedure. A nonrandomized study of 200 patients reported that gastric bypass and vertical-banded gastroplasty may be equally effective in achieving 40% excess weight loss, while a greater percentage of gastric bypass patients may achieve 50%–60% of excess weight loss.
 
Metabolic abnormalities are seen more frequently in gastric bypass patients compared to those receiving a vertical-banded gastroplasty. Anemia, iron deficiency, vitamin B 12 deficiency, and red blood cell folate deficiency are commonly seen. Marginal ulcerations are also seen in gastric bypasses, particularly in those whose gastric pouches are too large and include acid-secreting parietal cells.
 
Laparoscopic gastric bypass is intended to reproduce the open procedure via minimally invasive techniques.  This is a technically complex operation that requires a dedicated team and a relatively high degree of skill and experience in laparoscopic surgery. In addition, laparoscopic surgery is more difficult in general in obese patients compared to those closer to their ideal body weight. The data on the comparative efficacy of open versus laparoscopic bypass is limited by the lack of high-quality comparative studies, and the lack of systematic data collection on adverse events. Analysis of clinical series data suggests that weight loss at one year is similar for both procedures. However, the data raise concerns that serious short-term adverse events such as anastomotic leaks may be more frequent with the laparoscopic approach. The comparative rates of long-term adverse events cannot be reliably estimated from the available data.
 
The mini-gastric bypass has been primarily advocated by 1 surgeon. In 2001, Rutledge published his experience with 1,274 patients who underwent the mini-gastric bypass procedure.  The mean operating time was 36 minutes, and the mean hospital stay was 1.5 days. Mean excess weight loss was 51% at 6 months, 68% at 12 months, and 77% at 2 years. The overall complication rate reported was 5.2%. While this surgical approach may result in decreased surgical time, the anastomosis creates the risk of biliary reflux gastritis, one of the reasons that this anastomosis has been abandoned, in general, in favor of a Roux-en-Y anastomosis that diverts the biliary juices away from the stomach.
 
Adjustable Gastric Banding
Adjustable gastric banding, using an externally adjustable band placed around the stomach, has been extensively used in Europe, and 1 such device, the Lap-Band, has received approval from the U.S. Food and Drug Administration (FDA) in this country. The procedure is designed to mimic the vertical-banded gastroplasty, but be an easier, reversible, and flexible surgery. Similar to all gastric surgeries, the literature is dominated by large case series from individual surgeons who report varying results. In addition, gastric-banding surgery is still an evolving procedure with issues of band migration addressed by altering the position of the band and band erosion addressed by stabilizing the placement of the band. Therefore, it is very difficult to compare one series to another. For example, in this country, Doherty and colleagues reported on an initial experience with adjustable gastric banding in 40 patients.  The authors reported an unacceptable reoperation rate of 80%, primarily due to technical problems with the subcutaneously implanted reservoir. While those with an intact gastric band achieved 41% excess weight loss, the authors concluded that revisions to the surgical procedure and improvements in the device itself must be implemented. In a subsequent study, the authors reported several surgical modifications, including location of the gastric band and modifications in the device itself. Also, the surgery was performed laparoscopically. Seven of the 22 patients (33%) required reoperation, a considerable improvement.  In contrast to this American experience, as a representative example, Miller and Hell report a reoperation rate of only 7% in a case series of 158 patients.  Median BMI decreased from 44 kg/m-2 preoperatively to 28 kg/m-2 after 36 months. Suter and colleagues compared vertical-banded gastroplasty with laparoscopic gastric banding in consecutive case series and reported that laparoscopic gastric banding was associated with significant decrease in postoperative morbidity, primarily due to a decrease in thromboembolism and wound infections.  After 2 years of follow-up, there was no significant difference in weight loss between the 2 groups.
 
The data presented to the FDA as part of the FDA-approval process for the Lap-Band is summarized in the package insert.  In a group of 299 patients, the mean excess weight loss was 36.2% at 3 years. This figure contrasts with a 40%–60% excess weight loss reported in other series of vertical-banded gastroplasty and 50% for gastric bypass. One of the challenges of vertical-banded gastroplasty is dilation of the pouch, which may prompt surgical revision. The Lap-Band procedure is intended to address this complication, as any pouch dilation can be altered by percutaneous adjustment of the inflatable band. The incidence of adjustment of the band or how this maneuver affected weight loss is not provided in the package insert. For example, although a 24% incidence of band slippage or pouch dilation was reported, it was not reported whether this complication was resolved with adjustment of the gastric band. There was a 9% incidence of surgical revision procedures and an additional 24% of patients had their entire LapBand systems explanted, most commonly due to band slippage or pouch dilation, but also due to erosion, infection, or gastrointestinal disorders. It is very difficult to compare complication rates between procedures. The surgical complication rate for bariatric surgery varies widely from surgeon to surgeon, and the results reported for individual case series, typical of the literature of gastric bypass and vertical-banded gastroplasty, may not reflect the overall experience, as reported for the Lap-Band. However, without any comparative data, it cannot be determined whether the Lap-Band, particularly with its adjustable feature, is equivalent or offers any advantage over the accepted standard of vertical-banded gastroplasty or gastric bypass.
 
Biliopancreatic Bypass
The largest experience with biliopancreatic bypass is reported by Scopinaro, who developed the procedure. In 1996, Scopinaro summarized his experience with 1,217 patients.  The authors report that during the first 3 to 4 months after the surgery, patients have decreased appetites related to the dumping syndrome. These symptoms regressed with time, to the point that the majority of patients could resume eating large meals, with most patients eating more than they did before the operation. With follow-up of up to 9 years, the authors reported a durable excess weight loss of 75%, suggesting that weight loss is greater with this procedure compared to gastric restrictive procedures. In addition, the vast majority of patients reported disappearance of improvement of such complications as obstructive sleep apnea, hypertension, hypercholesteremia, and diabetes. The authors considered protein malnutrition the most serious metabolic complication, occurring in almost 12% of patients and responsible for 3 deaths. This complication may require inpatient treatment with total parenteral nutrition. To address the issue of protein malnutrition, 4% of patients underwent reoperation to either elongate the common limb (thus increasing protein absorption) or had the operation reversed, restoring normal intestinal continuity. The authors also found that protein malnutrition was strongly related to ethnicity, and presumably eating habits, of the patients, 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 are encouraged to maintain an oral calcium intake of 2 g daily, with monthly vitamin D supplementation.
 
Totte and colleagues in Belgium reported their experience with biliopancreatic bypass in 180 patients.  Prior to surgery the mean BMI was 48.8 kg/m-2, falling to 28.8 kg/m-2 at 36 months, corresponding to about 70% of excess weight loss. Six patients (3.3%) experienced serious perioperative complications including acute dilation of the stomach, diffuse peritonitis, and acute pancreatitis. Late complications included incisional hernia in 17%, anastomotic ulcers in 10%, and severe protein malnutrition requiring total parenteral nutrition in 1.1%. Obesity-related complications, such as diabetes, hypertension, or arthritis, resolved or improved in all patients. Nanni and colleagues reported on a case series of 59 patients.  Weight loss was similar, with 78% of excess weight loss after 2 years. Protein deficiency was noted in 2 (3.4%) patients.
 
The bulk of the experience with biliopancreatic bypass appears to be in Europe, particularly Italy. There are no case series reported in this country. According to Murr and colleagues, biliopancreatic bypass has not been widely accepted in this country due to unacceptable serious long-term morbidities. For example, biliopancreatic bypass has largely been abandoned at the Mayo Clinic due to the occurrence of steatorrhea, diarrhea, foul-smelling stools, severe bone pain, and the need for a life-long commitment to supplemental vitamins and minerals. In addition, there have been scattered case reports of liver damage, resulting either in death or liver transplant.  In addition, Murr hypothesizes that the incidence of protein malnutrition may be higher in this country compared to Scopinaro’s Italian series, since the North American diet has a higher percentage of fat and lesser amounts of carbohydrates.
 
Gastric Bypass with Long Limb (>100 cm)
As discussed in the Description section, the degree of malabsorption associated with long limb gastric bypass will vary with the length of the alimentary and biliary limbs. These modifications have been developed in an effort to decrease the metabolic side effects associated with biliopancreatic bypass. However, there has been limited reported experience. Murr reported on 26 patients who underwent a “very very long limb Roux-en-Y gastric bypass.”  In comparison to a case series of 11 patients who underwent biliopancreatic bypass, the authors reported similar weight loss but decreased metabolic or nutritional abnormalities, attributed in part to the increased length of the common segment, 100 cm, compared to 50 cm used in biliopancreatic bypass. Sugerman also attributes increasing the length of the common segment to decreasing metabolic morbidities.
 
Biliopancreatic Bypass with Duodenal Switch
The largest case series of the above procedure is reported by Marceau, who reported on 465 patients who underwent the duodenal switch procedure compared to 252 who underwent the biliopancreatic bypass.  It should be noted that in addition to the preservation of the duodenum, the common segment was elongated to 100 cm. The authors noted similar weight loss in the 2 groups. Also, in the duodenal switch group, there was a lower incidence of metabolic abnormalities such as protein malnutrition, which prompted reversal of the procedure in 1.7% of those undergoing biliopancreatic bypass versus. Only 0.1% after the duodenal switch procedure. However, it is not known whether this outcome is attributed to the lengthening of the common segment versus retention of the pylorus. Hess reported on a case series of 440 patients with variable lengths of the common channel.  The percentage excess weight loss varied between 60% and 90%, depending on the length of the common segment and alimentary limb. There were 2 late deaths, 1 due to septic shock secondary to an infected panniculus and 1 related to liver failure. A total of 10 patients underwent revision to lengthen the common segment secondary to low protein or excessive diarrhea. Seven patients underwent shortening of the common segment due to inadequate weight loss. Baltasar and colleagues reported on a case series of 60 patients undergoing the duodenal switch procedure with a common segment length of 75 cm.  One patient succumbed to liver failure and another due to malnutrition. The authors questioned the safety of the procedure.
 
Bariatric Surgery in the Super Obese
Two comparative studies were identified that compared the outcomes of standard short limb gastric bypass with long limb gastric bypass.  While both of these studies were considered to be of poor quality, due to non-comparability of groups, the reported % excess weight loss at 1 year was in the range of 55%–77%, similar to that seen with open gastric bypass. The limited data did not allow any conclusions about the comparative rates of complications of these procedures to standard gastric bypass.
 
Summary
As noted in the Policy section, this policy suggests that malabsorptive procedures for treatment of morbid obesity remain investigational. This interpretation of the term investigational may be questioned by those who would point out the procedure, particularly the Scopinaro procedure, has been performed for some 20 years with results of large case series reported in the peer- reviewed literature. The percent of excess weight loss, typically at or above 70%, may be higher than that reported with gastric restrictive procedures, reported at around 60%, but higher among those patients who maintain intact stomas.  One of the criteria used to define the term investigational, is whether the malabsorptive procedures are at least as good as the alternatives; i.e., gastric restrictive procedures. This involves a judgment as to whether the acknowledged increased metabolic risks associated with malabsorptive procedures are more than outweighed by an increased benefit associated with potentially greater weight loss. While most of the studies of bariatric surgeries report results in terms of weight loss, the degree of weight loss is essentially an intermediate outcome. For questions that ask whether surgery improves health outcomes, and/or how much surgery improves outcomes, weight loss by itself is useful only if the relationship between the amount of weight loss and the degree of improvement in health outcomes has been established. The underlying medical rationale for the surgery, and thus the basis for its coverage eligibility, is not the degree of weight loss, but the decreased risk of the morbid complications of obesity, i.e., a decreasing incidence of diabetes and cardiac risk factors, among others. While the psychosocial benefits of achieving normal weight may be compelling, they are not necessarily equivalent to the medical benefit. As noted by Brolin, a substantial number of morbidly obese patients experience marked improvement of medical problems with a relatively modest amount of weight loss. For example, in his case series of 130 patients undergoing bariatric surgery, over 90% experienced resolution or improvement in associated symptoms, even though only 41% of patients lost weight to within 50% of their ideal weight.   
 
Ideally, one would like to compare the incidence of morbidities in gastric restrictive versus malabsorptive procedures. However, there is no report of a head-to-head comparison among similar patients. It is difficult to compare results between case series due to variations in surgical procedures and different outcome measurements. In addition, the literature focuses on the degree of weight loss and not the incidence of obesity-related morbidities. However, it appears that the reduction in incidence of diabetes and cardiovascular risk factors is excellent with either a gastric restrictive or malabsorptive procedure. Therefore, this policy regarding the investigational status of malabsorptive procedures is based on the judgment that there is insufficient evidence to demonstrate that the increased risks of malabsorptive procedures compared to restrictive procedures are outweighed by a significantly greater reduction in obesity-related morbidities.
 
In the future, further modifications of malabsorptive procedures, including further experience with long limb gastric bypasses and refinement of surgical technique, may be associated with a declining risk of metabolic complications.
 
Obesity and obesity-related disease is increasing among adolescents in the United States.  There is no firm consensus on recommendations for the appropriate timing of bariatric surgery and optimal surgical and postoperative management of this patient group.  Several authors have recommended that adolescents who are candidates for bariatric surgery should be referred to centers with multidisciplinary weight management teams that have expertise in meeting the unique needs of overweight adolescents.  
 
It is hypothesized that the major and sustained weight loss for extremely obese adolescents who undergo bariatric surgery will result in improved overall health and quality of life just as it does for adults.  
 
In summarizing evidence for the U. S. Preventive Services Task Force, Whitlock and associates stated: “No acceptable quality evidence is available for adolescents, evaluating surgical approaches to overweight.  There are no controlled treatment outcome data on bariatric surgery approaches among adolescents.”
 
2008
The sleeve gastrectomy attempts to proportionately reduce both gastric size and the length of the small intestine so that all digestive functions are preserved and metabolic complications are less likely.  (Santoro et al).  This approach is based on the assumption that gastric capacity and the permeability of the small intestine exceed what is necessary for modern diets.  
 
Vidal et al reported on severely obese T2DM patients, 35 had SG and 50 had RYGB.  At 4 months both groups lost a similar amount of weight.  TSDM had resolved in 51.4% of those having SG and 62.0% of those having RYGB.
 
In 2006 Himpens et al published results of a study comparing laparoscopic gastric banding (GB) with laparoscopic sleeve gastrectomy (SG).
Sample                                 GB                                                       SG
                                             7M,  33 F                                             9 M, 31 F
Median age                            36                                                       40
Mediam BMI                           37                                                       39
                                             1 yr     3 yr                                          1yr     3 yr
Median wt loss(kg)                 14        17                                            26      29.5
Loss of feeling hunger
(% of patients)                       42.5       2.9                                         75        46.7
de novo GERD                       8.8% 20.5%                                         21.8%    3.1%
 
2008 Update - Endoscopic procedures
Drs. R.P. Petersen and A.D. Pryor, from the Duke Center for Weight Loss and Metabolic Surgery, Duke University Medical Center, and Dr. B. Chand, from the Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic recently reviewed the StomaphyX device along with other new morbid obesity procedures: “The StomaphyX device is currently available for the treatment of a dilated gastric pouch following gastric bypass. This device uses T-fasteners to create endoluminal plications that will decrease pouch size. The morbidity of this procedure appears minimal, but the benefit has yet to be proven.”
 
2009 Update
StomaphyX
The StomaphyX device was FDA approved in June 2007 for tissue approximation, ligation and full-thickness plication in the G.I. tract.  There are literature reports of its use for revisions in patients who have a dilated gastric pouch or stoma post gastric bypass surgery and more recently, for repair of gastric leaks.  This type of procedure is also known as: Natural Orifice Surgery (NOS)(Overcash, 2008); Natural Orifice Transluminal Endoscopic Surgery (NOTES)(de la Fuente, 2007); or  Revision Obesity Surgery Endoscopic (ROSE)(Mullady, 2009).
 
The American Society for Gastrointestinal Endoscopy (SAGE) published a guideline in 2008, Role of endoscopy in the bariatric surgery patient.  In the section Weight regain the following statement is made: Emerging technologies may allow endoscopic revision of the gastrojejunal anastomosis and reduction of the pouch size in patients with weight regain after an RYGB.
 
There are reports of this procedure in small numbers of patients, case or small case series, with short-term follow-up (Overcash, 2008; Mullady, 2009). There is also an ongoing trial, sponsored by EndoGastric Solutions, NCT00939055.  This is a phase II/III trial to evaluate the safety and effectiveness of a revisional incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss in post-RNYGB patients who have experienced weight regain.  This randomized controlled trial will compare StomaphyX versus sham in post-Roux-en-Y patients to reduce regained weight.  
 
Nguyen and colleagues published results of a randomized controlled trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity.  The trial randomized 197 subjects to either laparoscopic bypass or laparoscopic banding.  The percentage of weight loss was greater in the gastric bypass group with a treatment failure rate of 0%.  Treatment failure (<20% of excess weight loss) occurred in 16.7% of the patients that underwent gastric banding.  The complication rate, however, was higher in the gastric bypass group.  Major complications after bypass were bowel obstruction and stricture.  Interestingly, the male gender was a predictive factor of poor weight loss in this study.   The authors concluded, “Laparoscopic gastric bypass and gastric banding are both safe and effective approaches for the treatment of morbid obesity.  Gastric bypass resulted in better weight loss at medium- and long-term follow-up but was associated with more perioperative and late complications and a higher 30-day readmission rate” (Nguyen, 2009).
 
2011 Update
The policy was updated with a literature search using MEDLINE through February 2011.
 
Sleeve Gastrectomy
Brethauer and colleagues reviewed 36 studies (n=2,570) for a systematic review of SG as staged and primary procedure, the largest number (Rutledge, 2001) coming from European centers (Brethauer, 2009). Two RCTs, 1 nonrandomized matched cohort analysis, and 33 case series were examined. Thirteen studies (n=821) reported on high-risk patients having a staged approach and 24 studies (n=1,749) on SG as primary procedure. Mean percentage of excess weight loss (% EWL) was reported in 24 studies (n=1,662) and was 55.4% overall (range, 33–85%). Mean postoperative BMI was reported in 26 studies (n=1,940) and decreased from a baseline mean of 51.2 to 37.1. Other studies reported weight loss in terms of BMI decrease, percentage of BMI lost, or percentage of total weight lost, and all had significant reductions from baseline. Follow-up periods were 3–60 months. Ten studies included detailed postoperative co-morbidity data (n=754); more than 70% of patients had improvement or remission of type 2 diabetes, and significant reductions were seen in hypertension and hyperlipidemia, sleep apnea, and joint pain. The rate of major postoperative complications ranged from 0% to 23.8% for all studies and 0% to 15.3% in studies with greater 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 reporting detailed complication data (n=2,570). 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 and 3 in the primary procedure group). The authors comment that long-term follow-up is limited.
 
Recent additional case series that report similar outcomes with at least 2-year outcomes include the following. Sanchez-Sanchos et al. report on short and mid-term outcomes for 540 patients recorded in a National Registry in Spain (Sanchez-Santos, 2009). Mean follow-up was 16.5 + 10.6 months (1-73). Mean percent excess BMI loss (EBL) at 3 months was 38.8 + 22, 55.6 + 8 at 6 months, 68.1 + 28 at 12 months, and 72.4 + 31 at 24 months. Percentage of EWL was superior in patients with lower initial BMI and lower age. The morbidity rate was 5.2% and mortality rate 0.36%. Diabetes was remitted in 61% of patients and hypertension improved in 63.2%. Eighteen patients had a second-stage surgery. Complications presented more frequently in super-obese patients (odds ratio [OR], 2.8), male (OR, 2.98), and patients older than 55 years (OR, 2.8). The authors noted that more homogeneous and long-term studies are needed to determine the precise role of the procedure in bariatric surgery. Arias and colleagues report mid-term outcomes of 130 SGs (Arias, 2009). Mean BMI decreased to 36.9, 32.8, 29.5, 28, and 27.1 at 3, 6, 12 18, and 24 months, respectively. Percent of excess weight loss (% EWL) was 33.1, 50.8, 62.2, 64.4, and 67.9 at 3, 6, 12, 18, and 24 months, respectively.
Recently reported long-term studies show extensive weight loss; although, as with other procedures, weight gain often recurs over time. For example, in a study from Europe, Himpens and colleagues reported on 4- to 6-year follow-up results in a series of patients who had SG performed in 2001 and 2002 (Himpens, 2010). This study evaluated 53 consecutive morbidly obese patients who (according to the authors’ algorithm) qualified for restrictive surgery and were selected for LSG. Of the 53 patients, 11 received an additional malabsorptive procedure at a later stage because of weight regain. At six years, follow-up was obtained in 41 patients (78%). After 3 years, a mean EWL of 72.8% was documented, after 6 years EWL had dropped to 57.3%. These results included 11 patients who had benefited from an additional malabsorptive procedure (DS) and 2 patients who underwent a "resleeve" between the third and sixth postoperative year. In analyzing the results for the 30 patients receiving only SG, the authors found a 3-year % EWL of 77.5% and 6+ year % EWL of 53.3%. In addition, new gastroesophageal reflux complaints appeared in 21% of patients. In another study from Europe, D’Hondt et al. reported on long-term follow-up (median of 49 months) from review of 102 patients who underwent LSG (D’Hondt, 2011). A total of 83 patients (81.4%) were eligible for follow-up evaluation. The mean initial BMI was 39.3 kg/m2. At a median follow-up point of 49 months (range, 17-80 months), the mean % EWL was 72.3% ± 29.3%. For the 23 patients who reached the 6-year follow-up point, the mean % EWL was 55.9% ± 25.55%.
 
Three publications report findings for obese patients who had SG compared to other bariatric procedures. In a comparative study from France, Chouillard et al. performed a comparative analysis with 200 patients who had undergone either SG or RYGB between 2005 and 2008 (Chouillard, 2011). Patients in each group were matched for age, gender, and BMI. The postoperative complications, percentage of EWL, and the resolution of co-morbidities in each group were compared at 6, 12, and 18 months postoperatively. The overall mortality rates were similar in both groups. However, the morbidity rate was significantly greater in the RYGB group (20.5%) as compared to the SG group (6.5%; P<0.05). The overall remission of type 2 diabetes was significantly better in the RYGB group. However, the percentage of EWL at 6, 12, and 18 months, as well as the resolution of non-diabetic comorbidities, were comparable in both groups. The authors concluded that in this study, compared with SG, RYGB was associated with a greater short-term morbidity rate and RYGB could be associated with better diabetes control. They also note that additional studies are needed to evaluate the comparative efficacy of SG and RYGB for the treatment of morbid obesity and its co-morbidities. Lebya and colleagues reported on a series of 117 patients from Venezuela who were treated with either SG or RYGB (Leyba, 2011). From January 2008 to December 2008, 117 obese patients who met criteria for bariatric surgery were assigned by patient choice after informed consent to either a laparoscopic RYGB procedure (n=75) or an LSG procedure. Both groups were comparable in age, sex, BMI, and co-morbidities. Mean operative time of LSG was 82 minutes while LRYGB was 98 minutes (p<0.05). Differences in length of stay, major complications, improvement in co-morbidities, and EWL were not significant (p>0.05). One year after surgery, average EWL was 86% in LRYGB and 78.8% in LSG (p>0.05). The authors concluded that in the short term, both techniques are comparable regarding safety and effectiveness. In a comparative study from India, Lakdawala and colleagues compared 50 patients who underwent LSG and LRYGB from 2007 to 2008 (Lakdawala, 2010). Groups were matched for age, sex, and BMI. Patients were evaluated at 6 months and 1 year post-operatively. Resolution of most comorbidities such as type 2 diabetes, hypertension, dyslipidemia, sleep apnea, joint pain, and percentage of EWL in both groups was comparable at the end of 6 months and 1 year. Early resolution of type 2 diabetes was better in the LRYGB group; the results were comparable at 1 year. There was increased incidence of GERD in LSG patients. Chiu et al. reported a systematic review on the effect of SG on symptoms of GERD (Chiu, 2010). A total of 15 reports were retrieved; two reports analyzed GERD as a primary outcome, and 13 included GERD as a secondary study outcome. Of the 15 studies, 4 showed an increase in GERD after SG, 7 found reduced GERD prevalence after SG, 3 included only the postoperative prevalence of GERD, and 1 did not include data on prevalence of GERD. The authors concluded that the studies showed differing outcomes and that studies that objectively evaluate GERD after SG are needed.
 
Revision Procedures
A number of studies have evaluated the efficacy of revision procedures after failed bariatric surgery and reported satisfactory weight loss and resolution of co-morbidities with somewhat higher complication rates than for primary surgery. Mognol et al. reported on conversion of AGB to Roux-en-Y in 70 patients (Mognol, 2004). Indications for conversion were insufficient weight loss or weight regain after band deflation for gastric pouch dilatation in 34 patients (49%), inadequate weight loss in 17 patients (25%), symptomatic proximal gastric pouch dilatation in 15 patients (20%), intragastric band migration in 3 patients (5%), and psychological band intolerance in 1 patient. Median excess body weight loss was 70%. Sixty percent of patients achieved a BMI of less than 33 with mean follow-up 18 months. The early complication rate was 14.3% (10/70). Late major complications occurred in 6 patients (8.6%). Brolin and Cody, reporting on a series of 151 revision surgeries, observed that “Weight loss after revision of pure restrictive operations is significantly better than after revision of operations with malabsorptive components. Improvement of comorbidities in the great majority of patients justifies revision of all types of bariatric operations for unsatisfactory weight loss.” (Brolin, 2008) Beuter et al. reported that of 172 patients who underwent adjustable gastric band placement between May 1997 and June 2006, 41 had one or more revision procedures (Bueter, 2009). There were no deaths following the reoperations. Band replacement (n=18), band repositioning (n=7), conversion to SG (n=2) and Roux-en-Y gastric bypass (RYGBP, n=2) or band removal without any further substitution (n=12) were performed as first reoperation. Seven patients had a second reoperation. Median follow-up since reoperation was 56 months (range 7–113). Excess weight loss (EBWL %) of patients was 59.4% after RYGBP (n=5), 45.1% after re-banding (n=18), and 33.4% after SG (n=2). Comorbidities were further reduced or even resolved after reoperation.
 
Endoluminal/Endoscopic Procedures
Evidence of efficacy of endoluminal primary or revision bariatric procedures is very limited, consisting only of reports of a small number of case series, most from non-U.S. centers and with 20 or fewer subjects. The FDA has not cleared the gastric balloon for marketing in the United States. A survey of members of the American Society for Metabolic and Bariatric Surgery (ASMBS) bariatric surgeons have different risk tolerance and weight loss expectations for primary and revisional endoscopic procedures (Brethauer, 2009). They were “willing to accept less weight loss and more risk for revisional endoluminal procedures than for primary endoluminal procedures.” Durability of the procedures was a concern, and most surgeons were unwilling to consider the procedures until their efficacy has been proven.
 
Use of adjustable banding for BMI greater than 50
Updated information on selection of candidates for AGB, particularly with respect to the relationship between preoperative BMI and postoperative resolution of comorbidities, was also sought for this update. As noted in previous updates, comparative studies consistently demonstrate that patients who undergo AGB experience slower and smaller weight loss than those having gastric bypass or malabsorptive procedures. Brancatisano and colleagues (Brancatisano, 2008) identified 682 patients with type 2 diabetes, impaired glucose tolerance, and metabolic syndrome and at least a 6-month follow-up in their database of patients who received the Swedish Adjustable Band. They report that remission of type 2 diabetes was dependent on both the magnitude of excess weight loss (p=0.008) and the duration of existing diabetes (Brancatisano, 2008). Kadera et al. tested the hypothesis that RYGB improves type 2 diabetes by way of metabolic changes before significant weight loss occurs (Kadera, 2009). Of 1,546 patients with at least 12 months’ follow-up, 71 had type 2 diabetes and were taking insulin. Patients who achieved remission, defined as a cessation of diabetic medications and a hemoglobin A1c level of less than 7%, were compared with those who did not achieve remission. All 71 patients achieved a reduction in the dose of and/or number of medications at 30 months, and 35 (49%) demonstrated remission. By multivariate analysis, the significant factors associated with remission were preoperative insulin dose and percent of EWL. The % EWL was greater in the remission group as early as 3 months after surgery (p=0.04) and at 6, 12, 18, and 24 months. Citing a number of studies, Snyder et al. state that “it has become clear through most physicians’ clinical experience that those with a greater starting body mass index do not lose as much excess weight as those with a lower starting BMI.” (Snyder, 2009) To determine at what point the BMI is too great for effective weight loss, they collected weight loss data for 430 patients who had had an adjustable gastric band placed and stratified the % EWL within 1 year for patients with a BMI of 30–59, for BMI groups of 30–39, 30–49, and 50–59 and compared it with the average % EWL over time. Patients with a BMI less than 46 had a 50% EWL at 1 year, while those with a BMI greater than 46 had a 33% EWL. The % EWL was significantly different between groups at all measured intervals (p<0.0001). The authors conclude that “a BMI of 46 kg/m2 identifies those at high risk of failure to lose a significant percentage of excess weight after adjustable banding and who require closer follow-up” and that “patients should be advised that their weight loss might be suboptimal at 1 year”. Buchwald et al. conducted a systematic review that included 621 studies with 888 treatment arms and 135,246 patients; 103 treatment arms with 3,188 patients reported on resolution of diabetes (Buchwald, 2009). Nineteen studies with 43 treatment arms and 11,175 patients reported both weight loss and diabetes resolution separately for 4,070 diabetic patients. Percent of EWL was greatest for patients who had biliopancreatic diversion/duodenal switch, followed by gastric bypass, gastroplasty, and least for banding procedures. Overall, 78.1% of diabetic patients had complete resolution and 86.6% had improvement or resolution. Diabetes resolution by procedure was as follows: biliopancreatic diversion/duodenal switch (95.1% resolved), gastric bypass (80.3%), gastroplasty (79.7%), and laparoscopic AGB (56.7% resolved). With few exceptions, studies of AGB include patients with preoperative mean BMIs less than 45 and only a very few include patients with BMIs greater than 50. Few papers report detailed outcomes on resolution of comorbidities in patients with BMIs greater than 50 who received AGBs; sample sizes are very small, resolution in comorbidity is not defined, or reduction and resolution may be combined in outcome measures. Angrisani et al. performed a retrospective analysis of the multicenter Italian experience in patients with BMI greater than 50 who had AGB over a 4-year period (Angrisani, 2002). Of 1,797 having the procedure, 239 had BMI greater than 50 (mean 54.6). Mean % EWL was 34.1 (198 of 198 patients available for follow-up) at 12 months. Of the 12 patients who were diagnosed with diabetes preoperatively, 1 achieved resolution (fasting glycemia <110 mg/dL and HbA1c <6% without medication) at 1 year. Tice et al. compared outcomes of LAGB and RYGB in a systematic review (Tice, 2008). In 5 of the 14 included studies, BMI was 50 or more, comparative data on comorbidities was reported in 1. In that study, (reviewed in the 2008 update [Bowne, 2006]) 100% of patients in the RYGB group achieved resolution of diabetes versus 40% of those in the LAGB group. Resolution of hypertension was reported in 63% of RYGB and 27% of LAGB patients. The EWL was 52% in the RYGB group compared to 31% in the LAGB group. In another study reviewed in the previous update, Prarikh et al. compared resolution of diabetes after gastric banding (LAGB), gastric bypass (RYGB), and biliopancreatic diversion (BPD/DS) in 282 patients (Parikh, 2007). Preoperative BMIs were 47.2 in the LAGB group (n=218), 47.2 in the BPD/DS group (n=11). Percent EWL at 2 years was 50% in the LAGB group (68% of patients evaluated), 68% in the RYGB group (56% of patients evaluated), and 77% in the BPD/DS group (64% of patients evaluated). Preoperatively, oral hypoglycemics were used by 83% of the LapBand, 87% of the RYGB, and 82% of the BPD/DS patients and insulin was required by 18%, 28%, and 18%, respectively. At the 2-year follow-up, 34% of the LAGB group, 13% of the RYGB group, and 13% of the BPD/DS group required oral hypoglycemics and 18%, 13%, and 13%, respectively, required insulin.
 
Other Issues
Benotti and colleagues evaluated the impact of preoperative weight loss on surgical complications in a series of 881 patients undergoing open or laparoscopic gastric bypass from 2002 to 2006 (Benotti, 2009). Of the 881 patients, 592 (67.2%) lost 5% or more EBW and 423 (48.0%) lost more than 10% EBW. Controlling for age, sex, baseline BMI, and type of surgery in a multiple logistic regression model, increased preoperative weight loss was a predictor of reduced complications for any (p=0.004) and major (p=0.03) complications.
 
O’Brien et al. reported on a prospective, randomized trial from Australia of 50 adolescents between the ages of 14 and 18 with BMI greater than 35 who received either a lifestyle intervention or gastric banding and were followed up for 2 years (O’Brien, 2010). 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, the mean changes in the gastric-banding group were a weight loss of 34.6 kg (95% confidence interval [CI], 30.2-39.0), representing an excess weight loss of 78.8% (95% CI, 66.6-91.0%). The mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1-8.1), representing EWL of 13.2% (95% CI, 2.6%-21.0). The gastric banding group experienced improved quality of life with no perioperative adverse events; however, 8 operations (33%) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up. The authors concluded that among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight.
 
Practice Guidelines and Position Statements
In November 2009, the ASMBS updated its position on sleeve gastrectomy to state that it has accepted sleeve gastrectomy as an approved bariatric surgical procedure primarily because of its potential value as a first-stage operation for high-risk patients. They cite the need for long-term data to confirm the effectiveness of the procedure as a stand-alone intervention.  
 
In January 2009 the ASMBS Emerging Technologies and Clinical Issues Committee issued a Position Statement on Emerging Endosurgical Interventions for Treatment of Obesity. The committee stated that “use of novel technologies should be limited to clinical trials done in accordance with ethical guidelines of the ASMBS and designed to evaluate the risk and efficacy of the intervention.” It calls for trials to generate data for risk-benefit analysis, assessments of disability, durability, and resource utilization and notes that dramatic reduction in risk may allow for acceptance of interventions that do not provide durable benefits comparable to currently accepted bariatric procedures.
  
Updates 2012 and Later
 
“Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com”

CPT/HCPCS:
43631Gastrectomy, partial, distal; with gastroduodenostomy
43632Gastrectomy, partial, distal; with gastrojejunostomy
43633Gastrectomy, partial, distal; with Roux en Y reconstruction
43634Gastrectomy, partial, distal; with formation of intestinal pouch
43644Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux en Y gastroenterostomy (roux limb 150 cm or less)
43645Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption
43770Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device (eg, gastric band and subcutaneous port components)
43771Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric restrictive device component only
43772Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device component only
43773Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric restrictive device component only
43774Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components
43775Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy)
43842Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical banded gastroplasty
43845Gastric restrictive procedure with partial gastrectomy, pylorus preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)
43846Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux en Y gastroenterostomy
43847Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption
43886Gastric restrictive procedure, open; revision of subcutaneous port component only
43887Gastric restrictive procedure, open; removal of subcutaneous port component only
43888Gastric restrictive procedure, open; removal and replacement of subcutaneous port component only

References: . Hachem A, Brennan L(2015) Quality of Life Outcomes of Bariatric Surgery: A Systematic Review. Obes Surg. Oct 22 2015. PMID 26494369

. Lindekilde N, Gladstone BP, Lubeck M, et al.(2015) The impact of bariatric surgery on quality of life: a systematic review and meta-analysis. Obes Rev. Aug 2015;16(8):639-651. PMID 26094664

Abdelbaki TN, Huang CK, Ramos A, et al.(2012) Gastric plication for morbid obesity: a systematic review. Obes Surg. Oct 2012;22(10):1633-1639. PMID 22960951

Abdelbaki TN, Huang CK, Ramos A, et al.(2012) Gastric plication for morbid obesity: a systematic review. Obes Surg. Oct 2012;22(10):1633-1639. PMID 22960951

Afshar S, Kelly SB, Seymour K, et al.(2014) The effects of bariatric surgery on colorectal cancer risk: systematic review and meta-analysis. Obes Surg. Oct 2014;24(10):1793-1799. PMID 25015708

al-Haddad BJ, Dorman RB, Rasmus NF, et al.(2014) Hiatal hernia repair in laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass: a national database analysis. Obes Surg. Mar 2014;24(3):377-384. PMID 24307434

al-Haddad BJ, Dorman RB, Rasmus NF, et al.(2014) Hiatal hernia repair in laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass: a national database analysis. Obes Surg. Mar 2014;24(3):377-384. PMID 24307434

American Society for Gastrointestinal Endoscopy.(2008) Role of endoscopy in the bariatric surgery patient. Gastrointes Endosc, 2008; 68(1):1-10.

Andersen JR, Aasprang A, Karlsen TI, et al.(2015) Health-related quality of life after bariatric surgery: a systematic review of prospective long-term studies. Surg Obes Relat Dis. Mar-Apr 2015;11(2):466-473. PMID 25820082

Angrisani L, Furbeta F, Boldi SB et al.(2002) Results of the Italian multicenter study on 239 super-obese patients treated by adjustable gastric banding. Obes Surg 2002; 12(6):846-50.

Apovian CM, Baker C, et al.(2005) Best practice guidelines in pediatric/adolescent weight loss surgery. Obesity Res 2005; 13:274-82.

Ardestani A, Tavakkoli A.(2014) 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

Ardestani A, Tavakkoli A.(2014) 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

Arias E, Martínez PR, Ka Ming Li V et al.(2009) Mid-term follow-up after sleeve gastrectomy as a final approach for morbid obesity. Obes Surg 2009; 19(5):544-8.

Arterburn D, Wellman R, Emiliano A, et al.(2018) Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study. Ann. Intern. Med., 2018 Nov 2;169(11). PMID 30383139

Arterburn DE, Johnson E, Coleman KJ, et al.(2021) Weight Outcomes of Sleeve Gastrectomy and Gastric Bypass Compared to Nonsurgical Treatment. Ann Surg. Dec 01 2021; 274(6): e1269-e1276. PMID 32187033

Arterburn DE, Olsen MK, Smith VA, et al.(2015) Association between bariatric surgery and long-term survival. JAMA. Jan 6 2015;313(1):62-70. PMID 25562267

ASMBS Clinical Issues Committee.(2012) Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. May-Jun 2012;8(3):e21-26. PMID 22417852

Baltasar A, et al.(1998) Vertical banded gastroplasty at more than 5 years. Obes Surg 1998; 8:29-34.

Bariatric Surgery for Morbid Obesity. 2003 Blue Cross Blue Shield Association Technology Evaluation Center Assessment.

Benotti PN, Still CD, Wood GC et al.(2009) Preoperative weight loss before bariatric surgery. Arch Surg 2009; 144(12):1150-5.

Black JA, White B, Viner RM, et al.(2013) Bariatric surgery for obese children and adolescents: a systematic review and meta-analysis. Obes Rev. Aug 2013;14(8):634-644. PMID 23577666

Bower G, Toma T, Harling L, et al.(2015) Bariatric Surgery and Non-Alcoholic Fatty Liver Disease: a Systematic Review of Liver Biochemistry and Histology. Obes Surg. Dec 2015;25(12):2280-2289. PMID 25917981

Brancatisano A, Wahlroos S, Matthews S et al.(2008) Gastric banding for the treatment of type 2 diabetes mellitus in morbidly obese. Surg Obes Relat Dis 2008; 4(3)423-9.

Brethauer SA, Hammel JP, Schauer PR.(2009) Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 2009; 5(4):469-75.

Brethauer SA, Kothari S, Sudan R, et al.(2014) Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force. Surg Obes Relat Dis. Feb 22 2014. PMID 24776071

Brethauer SA, Pryor AD, Chand B et al.(2009) Endoluminal procedures for bariatric patients: expectations among bariatric surgeons. Surg Obes Rel Dis 2009; 5(2):231-6.

Brethauer SA, Pryor AD, et al.(2009) Endoluminal procedures for bariatric patients: expectations among bariatric surgeons. Surg Obes Relat Dis, 2009; 5(2):231-6.

Brolin RE, Cody RP.(2008) Weight loss outcome of revisional bariatric operations varies according to the primary procedure. Ann Surg 2008; 248(2):227-32.

Brown WA, de Leon Ballesteros GP, Ooi G, et al.(2021) Single Anastomosis Duodenal-Ileal Bypass with Sleeve Gastrectomy/One Anastomosis Duodenal Switch (SADI-S/OADS) IFSO Position Statement-Update 2020. Obes Surg. Jan 2021; 31(1): 3-25. PMID 33409979

Buchwald H, Avidor Y, Braunwald E et al.(2004) Bariatric surgery: a systematic review and meta-analysis. JAMA 2004; 292(14):1724-37.

Buchwald H, Estok R, Fahrbach K et al.(2009) Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med 2009; 122(3):248-56.

Bueter M, Thalheimer A, Wierlemann A et al.(2009) Reoperations after gastric banding: replacement or alternative procedures? Surg Endosc 2009; 23(2):334-40.

Capella JF, Capella RF.(1996) The weight reduction operation of choice: vertical banded gastroplasty or gastric bypass. Am J Surg 1996; 171:74-9.

Carmona MN, Santos-Sousa H, Lindeza L, et al.(2021) Comparative Effectiveness of Bariatric Surgeries in Patients with Type 2 Diabetes Mellitus and BMI 25 kg/m 2: a Systematic Review and Network Meta-Analysis. Obes Surg. Dec 2021; 31(12): 5312-5321. PMID 34611827

Castellana M, Procino F, Biacchi E, et al.(2021) Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy for Remission of Type 2 Diabetes. J Clin Endocrinol Metab. Mar 08 2021; 106(3): 922-933. PMID 33051679

Chang SH, Stoll CR, Song J, et al.(2014) The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg. Mar 2014;149(3):275-287. PMID 24352617

Chen W, Feng J, Wang C, et al.(2021) 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

Cheung D, Switzer NJ, Ehmann D, et al.(2015) The Impact of Bariatric Surgery on Diabetic Retinopathy: A Systematic Review and Meta-Analysis. Obes Surg. Sep 2015;25(9):1604-1609. PMID 25515499

Childerhose JE, Alsamawi A, Mehta T, et al.(2017) Adolescent bariatric surgery: a systematic review of recommendation documents. Surg Obes Relat Dis. Oct 2017;13(10):1768-1779. PMID 28958402

Chiu S, Birch DW, Shi X et al.(2010) Effect of sleeve gastrectomy on gastroesophageal reflux disease: a systematic review. Surg Obes Relat Dis 2010 Sept 21 [Epub ahead of print].

Chouillard EK, Karaa A, Elkhoury M et al.(2011) Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for morbid obesity: case-control study. Surg Obes Relat Dis 2011 Mar 8 [Epub ahead of print].

Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis 2010; 6(1):1-5. Available online at: http://www.asmbs.org/Newsite07/resources/Updated_Position_Statement_on_Sleeve_Gastrectomy.pdf. Last accessed May 2011.

Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery.(2010) Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. Jan-Feb 2010;6(1):1-5. PMID 19939744

Coffin B, Maunoury V, Pattou F, et al.(2017) Impact of intragastric balloon before laparoscopic gastric bypass on patients with super obesity: a randomized multicenter study. Obes Surg. Apr 2017;27(4):902-909. PMID 27664095

Cohen RV, Oliveira da Costa MV, Charry L, et al.(2019) Endoscopic gastroplasty to treat medically uncontrolled obesity needs more quality data: A systematic review. Surg Obes Relat Dis, 2019 May 28;15(7). PMID 31130406

Colquitt JL, Pickett K, Loveman E, et al.(2014) Surgery for weight loss in adults. Cochrane Database. Syst Rev. 2014;8:CD003641. PMID 25105982.

Cosentino C, Marchetti C, Monami M, et al.(2021) Efficacy and effects of bariatric surgery in the treatment of obesity: Network meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. Sep 22 2021; 31(10): 2815-2824. PMID 34348877

Courcoulas AP, Christian NJ, Belle SH, et al.(2013) Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. Dec 11 2013;310(22):2416-2425. PMID 24189773

Courcoulas AP, Gallagher JW, Neiberg RH, et al.(2020) Bariatric Surgery vs Lifestyle Intervention for Diabetes Treatment: 5-Year Outcomes From a Randomized Trial. J Clin Endocrinol Metab. Mar 01 2020; 105(3). PMID 31917447

Cowan GS, Buffington CK.(1998) Significant changes in blood pressure, glucose and lipids with gastric bypass surgery. World J Surg 1998; 22(9):987-92.

Cui BB, Wang GH, Li PZ, et al.(2021) Long-term outcomes of Roux-en-Y gastric bypass versus medical therapy for patients with type 2 diabetes: a meta-analysis of randomized controlled trials. Surg Obes Relat Dis. Jul 2021; 17(7): 1334-1343. PMID 33863632

Cummings DE, Cohen RV.(2016) Bariatric/Metabolic Surgery to Treat Type 2 Diabetes in Patients With a BMI <35 kg/m2. Diabetes Care, 2016 May 26;39(6). PMID 27222550

Cummings DE, Rubino F.(2017) Metabolic surgery for the treatment of type 2 diabetes in obese individuals. Diabetologia, 2017 Dec 11;61(2). PMID 29224190

Currie AC, Askari A, Fangueiro A, et al.(2021) Network Meta-Analysis of Metabolic Surgery Procedures for the Treatment of Obesity and Diabetes. Obes Surg. Oct 2021; 31(10): 4528-4541. PMID 34363144

Cuspidi C, Rescaldani M, Tadic M, et al.(2014) Effects of bariatric surgery on cardiac structure and function: a systematic review and meta-analysis. Am J Hypertens. Feb 2014;27(2):146-156. PMID 24321879.

D’Hondt M, Vanneste S, Pottel H et al.(2011) Laparoscopic sleeve gastrectomy as a single-stage procedure for the treatment of morbid obesity and the resulting quality of life, resolution of comorbidities, food tolerance, and 6-year weight loss. Surg Endosc 2011 Feb 27 [Epub ahead of print].

Dakin GF, Eid G, Mikami D, et al.(2013) Endoluminal revision of gastric bypass for weight regain—a systematic review. Surg Obes Relat Dis. May-Jun 2013;9(3):335-342. PMID 23561960

de Jonge C, Rensen SS, Verdam FJ, et al.(2013) Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. Sep 2013;23(9):1354-1360. PMID 23526068

de la Fuente SG, DeMaria EJ, et al.(2007) New developments in surgery. Arch Surg, 2007; 142:295-7.008

DeMaria EJ, Sugarman HJ, Meador JG, et al.(2001) High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity. Ann Surg 2001; 233:809-818.

Deviere J.(2008) Safety, feasibility and weight loss after transoral gastroplasty: First human multicenter study. Surg Ensosc. 2008;22(3):589-98.

Dixon JB, O'Brien PE, Playfair J et al.(2008) Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA 2008; 299(3):316-23.

Doherty C, Maher JW, Heitshusen DS.(1998) Prospective investigation of complications, reoperations and sustained weight loss with an adjustable gastric banding device for treatment of morbid obesity. J Gastrointest Surg 1998; 2(1):102-8.

Doherty C, Maher JW, Heitshusen DS.(1999) An interval report on prospective investigation of adjustable silicone gastric banding devices for the treatment of severe obesity. Eur J Gastroenterol Hepatol 1999; 11(2):115-9.

Driscoll S, Gregory DM, Fardy JM, et al.(2016) Long-term health-related quality of life in bariatric surgery patients: A systematic review and meta-analysis. Obesity (Silver Spring). Jan 2016;24(1):60-70. PMID 26638116

Durant N, Cox J.(2005) Current treatment approaches to overweight in adolescents. Curr Opin Pediat 2005; 17:454-9.

Eid GM, McCloskey CA, Eagleton JK, et al(2014) StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients : a randomized clinical trial. JAMA Surg. Apr 2014;149(4):372-379. PMID 24554030

Emerging Technologies and Clinical Issues Committees of the ASMBS. American Society for Metabolic and Bariatric Surgery Position Statement on emerging endosurgical interventions for treatment of obesity. Surg Obes Rel Dis 2009; 5(3):297-8. Available online at: http://www.asmbs.org/Newsite07/resources/emerging_tech_position.pdf. Last accessed May 2011.

Espinos JC, Turro R, Mata A, et al.(2013) Early experience with the Incisionless Operating Platform (IOP) for the treatment of obesity : the Primary Obesity Surgery Endolumenal (POSE) procedure. Obes Surg. Sep 2013;23(9):1375-1383. PMID 23591548

Executive Summary Clin Guidelines on the Identification; Evaluation; and Treatment Overweight and Obesity in Adults. National Hrt 1999; Lung and Blood Institute.

Executive summary: Guidelines (2013) for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society published by the Obesity Society and American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Based on a systematic review from the The Obesity Expert Panel, 2013. Obesity (Silver Spring). Jul 2014;22 Suppl 2:S5-39. PMID 24961825

Felsher J.(2004) A novel endolaparoscopic intragastric partitioning for treatment of morbid obesity. Surg Laparosc Endosc Percutan Tech. 2004;14(5):243–6.

Frezza EE, Barton A, Wachtel MS.(2008) 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

Frezza EE, Barton A, Wachtel MS.(2008) 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

Garcia VF.(2005) Adolescent bariatric surgery: treatment delayed may be treatment denied (letter to editor). Pediat 2005; 115:822-3.

Gloy VL, Briel M, Bhatt DL, et al.(2013) Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013;347:f5934. PMID 24149519

Gomes-Rocha SR, Costa-Pinho AM, Pais-Neto CC, et al.(2022) Roux-en-Y Gastric Bypass Vs Sleeve Gastrectomy in Super Obesity: a Systematic Review and Meta-Analysis. Obes Surg. Jan 2022; 32(1): 170-185. PMID 34642872

Greenstein R, Nissan A, Jaffin B.(1998) Esophageal Anatomy and Function in Laparoscopic Gastric Restrictive Bariatric Surgery: Implications for Patient Selection. Obes Surg. 1998/04/01 1998;8(2):199-206. PMID

Greenstein R, Nissan A, Jaffin B.(1998) Esophageal Anatomy and Function in Laparoscopic Gastric Restrictive Bariatric Surgery: Implications for Patient Selection. Obes Surg. 1998/04/01 1998;8(2):199-206. PMID

Groen VA, van de Graaf VA, Scholtes VA, et al.(2015) Effects of bariatric surgery for knee complaints in (morbidly) obese adult patients: a systematic review. Obes Rev. Feb 2015;16(2):161-170. PMID 25487972

Gu L, Huang X, Li S, et al.(2020) A meta-analysis of the medium- and long-term effects of laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. BMC Surg. Feb 12 2020; 20(1): 30. PMID 32050953

Gulkarov I, Wetterau M, Ren CJ, et al.(2008) 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

Gulkarov I, Wetterau M, Ren CJ, et al.(2008) 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

Han Y, Jia Y, Wang H, et al.(2020) Comparative analysis of weight loss and resolution of comorbidities between laparoscopic sleevegastrectomy and Roux-en-Y gastric bypass: A systematic review and meta-analysis based on 18 studies. Int J Surg. Apr 2020;76: 101-110. PMID 32151750

Hayes, Inc; October 2003.

Hell E, Miller KA, Moorehead MK, et al.(2000) Evaluation of health status and quality of life after bariatric surgery: comparison of standard Roux-en-Y gastric bypass, vertical banded gastroplasty and laparoscopic adjustable silicone gastric banding. Obes Surg 2000; 10(3):214-9.

Helmio M, Victorzon M, Ovaska J et al.(2012) SLEEVEPASS: a randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. Surg Endosc 2012; 26(9):2521-6.

Herron DM, Birkett DH, et al.(2008) Gastric bypass pouch and stoma reduction using a transoral endoscopic anchor placement system: a feasibility study. Surg Endosc, 2008; 22(4):1093-9.

Himpens J, Dobbeleir J, Peeters G.(2010) Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg 2010; 252(2):319-24.

Himpens K, Dapri G, Cadiere GB.(2006) A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg, 2006; 16:140-6.

Hofso D, Fatima F, Borgeraas H et al.(2019) Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol, 2019 Nov 5;7(12). PMID 31678062

Howard L, et al.(1995) Gastric Bypass and Vertical Banded Gastroplasty - a Prospective Randomized Comparison and 5 Year Follow-up. Obes Surg 1995; 5:55-60.

Hsieh T, Zurita L, Grover H, et al.(2014) 10-year outcomes of the vertical transected gastric bypass for obesity: a systematic review. Obes Surg. Mar 2014;24(3):456-461. PMID 24379176.

Hu B.(2005) Endoluminol gastroplasty with an endoscopic suture device. Endoscopy. 2005; 37(5):411-4.

Ibrahim AM, Thumma JR, Dimick JB.(2017) Reoperation and Medicare expenditures after laparoscopic gastric band surgery. JAMA Surg. Sep 1 2017;152(9):835-842. PMID 28514487

Ikramuddin S, Korner J, Lee WJ et al.(2013) Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. JAMA 2013; 309(21):2240-9.

Inge TH, Krebs NF, et al.(2004) Bariatric surgery for severely overweight adolescents: concerns and recommendations. Pediatrics 2004; 114:217-23.

Inge TH, Zeller M, Garcia VF, et al.(2004) Surgical approach to adolescent obesity. Adolesc Med 2004; 15: 429-453.

Inge TH, Zeller MH, Jenkins TM, et al.(2014) Perioperative outcomes of adolescents undergoing bariatric surgery: the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study. JAMA Pediatr. Jan 2014;168(1):47-53. PMID 24189578

Inge TH, Zeller MH, Lawson ML, et al.(2005) A critical appraisal of evidence supporting a bariatric surgical approach to weight management for adolescents. J Pediatrics 2005; 147:10-19.

Ji Y, Wang Y, Zhu J, et al.(2013) A systematic review of gastric plication for the treatment of obesity. Surg Obes Relat Dis. Dec 12 2013. PMID 24582413

Ji Y, Wang Y, Zhu J, et al.(2013) A systematic review of gastric plication for the treatment of obesity. Surg Obes Relat Dis. Dec 12 2013. PMID 24582413

Kadera BE, Lum K, Grant J et al.(2009) Remission of type 2 diabetes after Roux-en-y gastric bypass is associated with greater weight loss. Surg Obes Relat Dis 2009; 5(3):305-9.

Kalfarentzos F, et al.(1999) Vertical banded gastroplasty versus standard or distal Roux-en-Y gastric bypass based on specific selection criteria in the morbidly obese: preliminary results. Obes Surg 1999; 9:433-42.

Kang JH, Le QA.(2017) Effectiveness of bariatric surgical procedures: A systematic review and network meta-analysis of randomized controlled trials. Medicine (Baltimore). Nov 2017;96(46):e8632. PMID 29145284

Keidar A, Hershkop KJ, Marko L, et al.(2013) Roux-en-Y gastric bypass vs sleeve gastrectomy for obese patients with type 2 diabetes: a randomised trial. Diab tologia. Sep 2013;56(9):1914-1918. PMID 23765186

Koehestanie P, de Jonge C, Berends FJ, et al.(2014) The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. Dec 2014;260(6):984-992. PMID 25072436

Kohn GP, Price RR, DeMeester SR, et al.(2013) Guidelines for the management of hiatal hernia. Surg Endosc. Dec 2013;27(12):4409-4428. PMID 24018762

Kohn GP, Price RR, DeMeester SR, et al.(2013) Guidelines for the management of hiatal hernia. Surg Endosc. Dec 2013;27(12):4409-4428. PMID 24018762

Kolanowski J.(1995) Gastroplasty for morbid obesity: the internist’s view. Int J Obes Metab Disord 1995; 19(sup 3):S61-5.

Kotinda APST, de Moura DTH, Ribeiro IB, et al.(2020) Efficacy of Intragastric Balloons for Weight Loss in Overweight and Obese Adults: a Systematic Review and Meta-analysis of Randomized Controlled Trials. Obes Surg. Jul 2020; 30(7): 2743-2753. PMID 32300945

Kwok CS, Pradhan A, Khan MA, et al.(2014) Bariatric surgery and its impact on cardiovascular disease and mortality: a systematic review and meta-analysis. Int J Cardiol. Apr 15 2014;173(1):20-28. PMID 24636546.

Lakdawala MA, Bhasker A, Mulchandani D et al.(2010) Comparison between the results of laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass in the Indian population: a retrospective 1 year study. Obes Surg 2010; 20(1):1-6.

Lawson ML, Kirk S, et al.(2006) One-year outcomes of Roux-en-Y gastric bypass for morbidly obese adolescents: a multicenter study from the Pediatric Bariatric Study Group. J Pediat Surg 2006; 41:137-43.

Lee WJ, Wang W, Lee YC et al.(2008) Effect of laparoscopic mini-gastric bypass for type 2 diabetes mellitus: comparison of BMI>35 and <35 kg/m2. J. Gastrointest. Surg. 2008; 12(5):945-52.

Lee Y, Doumouras AG, Yu J, et al.(2021) Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Roux-en-Y Gastric Bypass: A Systematic Review and Meta-analysis of Weight Loss, Comorbidities, and Biochemical Outcomes From Randomized Controlled Trials. Ann Surg. Jan 01 2021; 273(1): 66-74. PMID 31693504

Leyba JL, Aulestia SN, Liopis SN.(2011) Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the treatment of morbid obesity. A prospective study of 117 patients. Obes Surg 2011; 21(2):212-6.

Li H, Wang J, Wang W, et al.(2021) Comparison Between Laparoscopic Sleeve Gastrectomy and Laparoscopic Greater Curvature Plication Treatments for Obesity: an Updated Systematic Review and Meta-Analysis. Obes Surg. Sep 2021; 31(9): 4142-4158. PMID 34227019

Li JF, Lai DD, Ni B, et al.(2013) Comparison of laparoscopic Roux-en-Y gastric bypass with laparoscopic sleeve gastrectomy for morbid obesity or type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. Can J Surg. Dec 2013;56(6):E158-164. PMID 24284156

Liu DF, Ma ZY, Zhang CS, et al.(2021) The effects of bariatric surgery on dyslipidemia and insulin resistance in overweight patients with or without type 2 diabetes: a systematic review and network meta-analysis. Surg Obes Relat Dis. Sep 2021; 17(9): 1655-1672. PMID 3422993

Lopes EC, Heineck I, Athaydes G, et al.(2015) Is Bariatric Surgery Effective in Reducing Comorbidities and Drug Costs? A Systematic Review and Meta-Analysis. Obes Surg. Sep 2015;25(9):1741-1749. PMID 26112137

Madadi F, Jawad R, Mousati I, et al.(2019) Remission of Type 2 Diabetes and Sleeve Gastrectomy in Morbid Obesity: a Comparative Systematic Review and Meta-analysis. Obes Surg. Dec 2019; 29(12): 4066-4076. PMID 31655953

Maggard MA, Shugarman LR, Suttorp M et al.(2005) Meta-analysis: surgical treatment of obesity. Ann. Intern. Med. 2005; 142(7):547-59.

Manco M, Mosca A, De Peppo F, et al.(2017) The benefit of sleeve gastrectomy in obese adolescents on nonalcoholic steatohepatitis and hepatic fibrosis. J Pediatr. Jan 2017;180:31-37 e32. PMID 27697327

Matar R, Monzer N, Jaruvongvanich V, et al.(2021) Indications and Outcomes of Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass: a Systematic Review and a Meta-analysis. Obes Surg. Sep 2021; 31(9): 3936-3946. PMID 34218416

Mechanick JI, Youdim A, Jones DB et al.(2013) Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient-- 2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Relat Dis 2013; 9(2):159-91.

Melissas J, Christodoulakis M, Spyridakis M, et al.(1998) Disorders associated with clinically severe obesity: significant improvement after surgical weight reduction. South Med J 1998; 91(12): 1143-8.

Miller K, Hell E.(1999) Laparoscopic adjustable gastric banding: a prospective 4-year follow-up study. Obes Surg 1999; 9(2):183-7.

Mingrone G, Panunzi S, De Gaetano A et al.(2012) Bariatric surgery versus conventional medical therapy for type 2 diabetes. N. Engl. J. Med. 2012; 366(17):1577-85.

Mognol P, Chosidow D, Marmuse JP.(2004) Laparoscopic conversion of laparoscopic gastric banding to Roux-en-Y gastric bypass: a review of 70 patients. Obes Surg 2004; 14(10):1349-53.

Morton JM.(2007) Weight gain after bariatric surgery as a result of large gastric stoma: endotherapy with sodium morrhuate to induce stomal stenosis may prevent the need for surgical revision. Gastrointest Endosc. Aug 2007;66(2):246-247. PMID 17643696

Mullady DK, Lautz DB, Thompson CC.(2009) Treatment of weight regain after gastric bypass surgery when using a new endoscopic platform: initial experience and early outcomes (with video). Gastrointest Endosc, 2009 Jun 23 [Epub ahead of print].

Muller-Stich BP, Senft JD, Warschkow R, et al.(2015) Surgical versus medical treatment of type 2 diabetes mellitus in nonseverely obese patients: a systematic review and meta-analysis Ann Surg. Mar 2015;261(3):421-429. PMID 25405560

Murr MM, Balsiger BM, Kennedy FP, et al.(1999) Malabsorptive procedures for severe obesity: comparison of pancreaticobiliary bypass and very long limb Roux-en-Y gastric bypass. J Gastrointest Surg 1999; 3(6):607-12.

Nanni G, Balduzzi GF, Capoluongo R, et al.(1997) Biliopancreatic diversion: clinical experience. Obes Surg 1997; 7(1):26-9.

National Institutes of Health. Consensus Development Conference Panel. Gastrointestinal surgery for severe obesity. Ann Intern Med 1991;115(12):956-61.

Nguyen NT, Slone JA, Nguyen XM, et al.(2009) A prospective randomized trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity: outcomes, quality of life and costs. Ann Surg. 2009 Oct; 250:631.

Nobili V, Vajro P, Dezsofi A, et al.(2015) Indications and limitations of bariatric intervention in severely obese children and adolescents with and without nonalcoholic steatohepatitis: ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. Apr 2015;60(4):550-561. PMID 25591123

O’Brien PE, Sawyer SM, Laurie C et al.(2010) Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. JAMA 2010; 303(6):519-26.

Obermayer A, Tripolt NJ, Aziz F, et al.(2021) EndoBarrier Implantation Rapidly Improves Insulin Sensitivity in Obese Individuals with Type 2 Diabetes Mellitus. Biomolecules. Apr 14 2021; 11(4). PMID 33919949

Olbers T, Beamish AJ, Gronowitz E, et al.(2017) Laparoscopic Roux-en-Y gastric bypass in adolescents with severe obesity (AMOS): a prospective, 5-year, Swedish nationwide study. Lancet Diabetes Endocrinol. Mar 2017;5(3):174-183. PMID 28065734

Osland E, Yunus RM, Khan S, et al.(2017) Weight loss outcomes in laparoscopic vertical sleeve gastrectomy (LVSG) versus laparoscopic roux-en-y gastric bypass (LRYGB) procedures: a meta-analysis and systematic review of randomized controlled trials. Surg Laparosc Endosc Percutan Tech. Feb 2017;27(1):8-18. PMID 28145963

Osland EJ, Yunus RM, Khan S, et al.(2020) Five-Year Weight Loss Outcomes in Laparoscopic Vertical Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) Procedures: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Surg Laparosc Endosc Percutan Tech. Dec 2020; 30(6): 542-553. PMID 32658120

Overcash WT.(2008) Natural Orifice Surgery (NOS) using StomaphyX for repair of gastric leaks after bariatric revisions. Obes Surg, 2008; 18(7):882-5.

Park CH, Nam SJ, Choi HS, et al.(2019) Comparative Efficacy of Bariatric Surgery in the Treatment of Morbid Obesity and Diabetes Mellitus: a Systematic Review and Network Meta-Analysis. Obes Surg, 2019 May 1;29(7). PMID 31037599

Parmar CD, Gan J, Stier C, et al.(2020) One Anastomosis/Mini Gastric Bypass (OAGB-MGB) as revisional bariatric surgery after failed primary adjustable gastric band (LAGB) and sleeve gastrectomy (SG): A systematic review of 1075 patients. Int J Surg. Sep 2020; 81:32-38. PMID 32738545

Pattanshetti S, Tai CM, Yen YC, et al.(2013) Laparoscopic adjustable gastric banded plication: evolution of procedure and 2-year results. Obes Surg. Nov 2013;23(11):1934-1938. PMID 24013809

Pattanshetti S, Tai CM, Yen YC, et al.(2013) Laparoscopic adjustable gastric banded plication: evolution of procedure and 2-year results. Obes Surg. Nov 2013;23(11):1934-1938. PMID 24013809

Petersen RP, Chand B, Pryor AD.(2008) Endoluminal treatment options for morbid obesity: devices and techniques for natural orifice approaches. Bariatric Times; 2008: http://bariatrictimes.com.

Petrucciani N, Martini F, Benois M, et al.(2021) Revisional One Anastomosis Gastric Bypass with a 150-cm Biliopancreatic Limb After Failure of Adjustable Gastric Banding: Mid-Term Outcomes and Comparison Between One- and Two-Stage Approaches. Obes Surg. Dec 2021; 31(12): 5330-5341. PMID 34609712

Pilone V, Vitiello A, Hasani A, et al.(2014) Laparoscopic Adjustable Gastric Banding Outcomes in Patients with Gastroesophageal Reflux Disease or Hiatal Hernia. Obes Surg. Jul 17 2014. PMID 25030091

Pilone V, Vitiello A, Hasani A, et al.(2014) Laparoscopic Adjustable Gastric Banding Outcomes in Patients with Gastroesophageal Reflux Disease or Hiatal Hernia. Obes Surg. Jul 17 2014. PMID 25030091.

Pories WJ, Swanson MS, MacDonald KG, et al.(1995) Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995; 222(3):339-52.

Position statement on sleeve gastrectomy as a bariatric procedure. American Society for Metabolic and Bariatric Surgery; 2007:www.asmbs.org.

Puzziferri N, Roshek TB, 3rd, Mayo HG, et al.(2014) Long-term follow-up after bariatric surgery: a systematic review. JAMA. Sep 3 2014;312(9):934-942. PMID 25182102

Qi L, Guo Y, Liu CQ, et al.(2017) Effects of bariatric surgery on glycemic and lipid metabolism, surgical complication and quality of life in adolescents with obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. Dec 2017;13(12):2037-2055. PMID 29079384

Rand CS, Magregor M.(1994) Adolescents Having Obesity Surgery: A 6 Year Followup. South Med J 1994; 87:1208-1213.

Rao WS, Shan CX, Zhang W, et al.(2014) A Meta-Analysis of Short-Term Outcomes of Patients with Type 2 Diabetes Mellitus and BMI
Reynoso JF, Goede MR, Tiwari MM, et al.(2011) 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

Reynoso JF, Goede MR, Tiwari MM, et al.(2011) 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

Ricci C, Gaeta M, Rausa E, et al.(2014) Early impact of bariatric surgery on type II diabetes, hypertension, and hyperlipidemia: a systematic review, meta-analysis and meta-regression on 6,587 patients. Obes Surg. Apr 2014;24(4):522-528. PMID 24214202

Ricci C, Gaeta M, Rausa E, et al.(2015) Long-term effects of bariatric surgery on type II diabetes, hypertension and hyperlipidemia: a meta-analysis and meta-regression study with 5-year follow-up. Obes Surg. Mar 2015;25(3):397-405. PMID 25240392

Rohde U, Hedback N, Gluud LL, et al.(2015) Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: Systematic review and meta-analysis. Diabetes Obes Metab. Nov 5 2015. PMID 26537317

Rutledge R.(2001) The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg 2001; 11(3):276-80.

Ryou M, Ryan MB, Thompson CC.(2011) Current status of endoluminal bariatric procedures for primary and revision indications. Gastrointest Endosc Clin N Am. Apr 2011;21(2):315-333. PMID 21569983

Sanchez-Pernaute A, Rubio MA, Cabrerizo L, et al.(2015) Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. Sep-Oct 2015;11(5):1092-1098. PMID 26048517

Sánchez-Santos R, Masdevall C, Baltasar A et al.(2009) Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg 2009;19(9):1203-10.

Santonicola A, Angrisani L, Cutolo P, et al.(2014) 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

Santonicola A, Angrisani L, Cutolo P, et al.(2014) 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

Santoro S, Velhote MC, et al.(2006) Preliminary results from digestive adaptation: a new surgical proposal for treating obesity, based on physiology and evolution. Sao Paulo Med J, 2006; 124:192-7.

Schauer PR, Bhatt DL, Kirwan JP, et al.(2014) Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. N Engl J Med. May 22 2014;370(21):2002-2013. PMID 24679060

Schauer PR, Kashyap SR, Wolski K et al.(2012) Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N. Engl. J. Med. 2012; 366(17):1567-76.

Schweitzer M.(2004) Endoscopic intraluminal suture plication of the gastric pouch and stoma in postoperative Roux-en-Y gastric bypass patients. J Laparoendosc Adv Surg Tech A, 2004; 14:223-6.

Scopinaro N, Gianetta E, Adami GF, et al.(1996) Biliopancreatic diversion for obesity at eighteen years. Surgery 1996; 119(3):261-8.

Scopinaro N, Papadia F, Marinari G et al.(2007) Long-term control of type 2 diabetes mellitus and the other major components of the metabolic syndrome after biliopancreatic diversion in patients with BMI < 35 kg/m2. Obes Surg 2007; 17(2):185-92.

Sharples AJ, Mahawar K.(2020) Systematic Review and Meta-Analysis of Randomised Controlled Trials Comparing Long-Term Outcomes of Roux-En-Y Gastric Bypass and Sleeve Gastrectomy. Obes Surg. Feb 2020; 30(2): 664-672. PMID 31724116

Shenoy SS, Gilliam A, Mehanna A, et al.(2020) Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Roux-en-Y Gastric Bypass in Elderly Bariatric Patients: Safety and Efficacy-a Systematic Review and Meta-analysis. Obes Surg. Nov 2020; 30(11): 4467-4473. PMID32594469

Shoar S, Poliakin L, Rubenstein R, et al.(2018) Single Anastomosis Duodeno-Ileal Switch (SADIS): A Systematic Review of Efficacy andSafety. Obes Surg. Jan 2018; 28(1): 104-113. PMID 28823074

Simonson DC, Vernon A, Foster K, et al.(2019) Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial. Surg Obes Relat Dis. Dec 2019; 15(12): 2052-2059. PMID 31931977

Sjostrom CD, Lissner L, Wedel H et al.(1999) Reduction in incidence of diabetes, hypertension and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS Intervention Study. Obes. Res. 1999; 7(5):477-84.

Sjostrom L, Lindroos AK, Peltonen M et al.(2004) Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N. Engl. J. Med. 2004; 351(26):2683-93.

Sjostrom L, Narbro K, Sjostrom CD et al.(2007) Effects of bariatric surgery on mortality in Swedish obese subjects. N. Engl. J. Med. 2007; 357(8):741-52.

Skogar ML, Sundbom M.(2017) Duodenal switch is superior to gastric bypass in patients with super obesity when evaluated with the Bariatric Analysis and Reporting Outcome System (BAROS). Obes Surg. Sep 2017;27(9):2308-2316. PMID 28439748

Snyder B, Scarborough T, Yu S et al.(2009) Failure of adjustable gastric banding: starting BMI of 46 kg/m2 is a fulcrum of success and failure. Surg Obes Relat Dis 2009; 5(3):310-6.

Speiser PW, Rudolf MCJ, Anhalt H, et al.(2005) Consensus Statement: Childhood Obesity. J Clinical Endoc and Metabolism 2005; 90:3; March 1871-87.

Staroli AA.(2005) Prospective feasibility study of gastrojejunostomy anastomotic size reduction by endoluminal gastroplication in patients with postgastric bypass recidivism. Gastrointest Endosc. 2005;61:AB240.

Strain GW, Torghabeh MH, Gagner M, et al.(2017) Nutrient status 9 years after biliopancreatic diversion with duodenal switch (BPD/DS): an observational study. Obes Surg. Jul 2017;27(7):1709-1718. PMID 28155056

Sudan R, Nguyen NT, Hutter MM, et al.(2014) Morbidity, Mortality, and Weight Loss Outcomes After Reoperative Bariatric Surgery in the USA. J Gastrointest Surg. Sep 4 2014. PMID 25186073

Sullivan S, Swain JM, Woodman G, et al.(2017) Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial. Obesity (Silver Spring). Feb 2017;25(2):294-301. PMID 28000425

Suter M, Giusti V, Heraief E, et al.(1999) Early results of laparoscopic gastric banding compared with open vertical banded gastroplasty. Obes Surg 1999; 9(4):374-80.

Talebpour M, Motamedi SM, Talebpour A, et al.(2012) Twelve year experience of laparoscopic gastric plication in morbid obesity: development of the technique and patient outcomes. Ann Surg Innov Res. 2012;6(1):7. PMID 22913751

Talebpour M, Motamedi SM, Talebpour A, et al.(2012) Twelve year experience of laparoscopic gastric plication in morbid obesity: development of the technique and patient outcomes. Ann Surg Innov Res. 2012;6(1):7. PMID 22913751

Talebpour M, Sadid D, Talebpour A, et al.(2017) Comparison of short-term effectiveness and postoperative complications: laparoscopic gastric plication vs laparoscopic sleeve gastrectomy. Obes Surg. Oct 17 2017. PMID 29043548

Tate CM, Geliebter A.(2017) Intragastric balloon treatment for obesity: review of recent studies. Adv Ther. Aug 2017;34(8):1859-1875. PMID 28707286

Thompson CC, Abu Dayyeh BK, Kushnir V, et al.(2019) Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial. Surg Obes Relat Dis, 2019 Jul 16;15(8). PMID 31302000

Thompson CC.(2006) Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: A possible new option for patients with weight regain. Surg Endosc. 2006;20(11):1744-8.

Tice JA, Karliner L, Walsh J et al.(2008) Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med 2008; 121(10):885-93.

Torgerson JS, Sjostrom L.(2001) The Swedish Obese Subjects (SOS) study--rationale and results. Int. J. Obes. Relat. Metab. Disord. 2001; 25 Suppl 1:S2-4.

Torres A, Rubio MA, Ramos-Levi AM, et al.(2017) Cardiovascular risk factors after single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S): a new effective therapeutic approach? Curr Atheroscler Rep. Nov 7 2017;19(12):58. PMID 29116413

Totte E, Hendricks L, van Hee R.(1999) Biliopancreatic diversion for treatment of morbid obesity: experience in 180 consecutive cases. Obes Surg 1999; 9(2):161-5.

Towbin A, Inge TH, Garcia VF, et al.(2004) Beriberi after gastric bypass surgery in adolescence. J Pediatrics 2004; August:263-267.

Trastulli S, Desiderio J, Guarino S, et al.(2013) Laparoscopic sleeve gastrectomy compared with other bariatric surgical procedures: a systematic review of randomized trials. Surg Obes Relat Dis. Sep- Oct 2013; 9(5):816-829. PMID 23993246

Trelles N, Gagner M.(2007) Sleeve gastrectomy. Oper Techn Gen Surg, 2007; 9:123-31.

Van Gemert WG, et al.(1998) Revisional Surgery after failed vertical banded gastroplasty: restoration of vertical banded gastroplasty or conversion to gastric bypass. Obes Surg 1998; 8:21-8.

Vidal J, Ibarzabal A, et al.(2007) Short-term effects of sleeve gastrectomy on type 2 diabetes mellitus in severely obese subjects. Obes Surg, 2007; 17:1069-74.

Wang MC, Guo XH, Zhang YW, et al.(2015) Laparoscopic Roux-en-Y gastric bypass versus sleeve gastrectomy for obese patients with Type 2 diabetes: a meta-analysis of randomized controlled trials. Am Surg. Feb 2015;81(2):166-171. PMID 25642879

Weiner RA, Weiner S, et al.(2007) Laparoscopic sleeve gastrectomy - influence of sleeve size and resected gastric volume. Obes Surg, 2007; 17:1297-305.

Whitlock EP, Williams SB, et al.(2005) Screening and interventions for childhood overweight: a summary of evidence for US Preventive Services Task Force. Pediat 2005; 116:124-44.

Wiggins T, Guidozzi N, Welbourn R, et al.(2020) Association of bariatric surgery with all-cause mortality and incidence of obesity-related disease at a population level: A systematic review and meta-analysis. PLoS Med. Jul 2020; 17(7): e1003206. PMID 32722673

Wilhelm SM, Young J, Kale-Pradhan PB.(2014) Effect of bariatric surgery on hypertension: a metaanalysis. Ann Pharmacother. Jun 2014;48(6):674-682. PMID 24662112.

Willcox K, Brennan L.(2014) 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

Wolnerhanssen BK, Peterli R, Hurme S, et al.(2021) Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy: 5-year outcomes of merged data from two randomized clinical trials (SLEEVEPASS and SM-BOSS). Br J Surg. Jan 27 2021; 108(1): 49-57. PMID 33640917

Xu C, Yan T, Liu H, et al.(2020) Comparative Safety and Effectiveness of Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in Obese Elder Patients: a Systematic Review and Meta-analysis. Obes Surg. Sep 2020; 30(9): 3408-3416. PMID 32277330

Yan G, Wang J, Zhang J, et al.(2019) Long-term outcomes of macrovascular diseases and metabolic indicators of bariatric surgery for severe obesity type 2 diabetes patients with a meta-analysis. PLoS One. 2019; 14(12): e0224828. PMID 31794559

Yang XW, Li PZ, Zhu LY, et al.(2015) Effects of bariatric surgery on incidence of obesity-related cancers: a meta-analysis. Med Sci Monit. May 11 2015; 21: 1350-7. PMID 25961664

Zhang Y, Ju W, Sun X, et al.(2014) Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Roux-En-Y Gastric Bypass for Morbid Obesity and Related Comorbidities: A Meta-Analysis of 21 Studies. Obes Surg. Aug 5 2014. PMID 25092167


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