When is gastric bypass surgery medically necessary

It states that "Endoscopic gastrointestinal bypass devices EGIBD — A barrier device is deployed to prevent luminal contents from being absorbed in the proximal small intestine. The EndoBarrier is cm long and it extends from the proximal duodenum to the mid-jejunum and thus mimics a duodenojejunal bypass.

The ValenTx is a cm barrier device that extends from the gastroesophageal junction to the jejunum. Data are still lacking about the longevity of these endobarriers and their outcomes once the barrier is removed". The EndoBarrier, an endoscopically delivered duodeno-jejunal bypass liner DJBL , is a plastic flexible tube that is placed in the duodenal bulb, directly behind the pylorus. It extends from the duodenum to the proximal jejunum. Recent studies have suggested that the use of EndoBarrier has resulted in significant weight reduction in comparison to control-diet patients.

Schouten et al noted that the endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients. These researchers reported on the first European experience with this device. A multi-center, randomized clinical trial was performed. A total of 41 patients were included and 30 underwent sleeve implantation; 11 patients served as a diet control group. All patients followed the same low-calorie diet during the study period.

The purpose of the study was to determine the safety and effectiveness of the device. A total of 26 devices were successfully implanted.

In 4 patients, implantation could not be achieved. The remaining patients all completed the study. Mean procedure time was 35 mins range of 12 to for a successful implantation and 17 mins range of 5 to 99 for explantation.

There were no procedure related adverse events. Initial mean BMI was Mean excess weight loss after 3 months was Absolute change in BMI at 3 months was 5. Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period lower glucose levels, glycated hemoglobin [HbA1c], and medication requirements. The authors concluded that the EndoBarrier Gastrointestinal Liner is a feasible and safe non-invasive device with excellent short-term weight loss results.

The device also has a significant positive effect on type 2 diabetes mellitus. Moreover, they stated that long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity. Escalona et al evaluated safety, weight loss, and cardio-metabolic changes in obese subjects implanted with the DJBL for 1 year.

Morbidly obese subjects were enrolled in a single-arm, open-label, prospective trial and implanted with the DJBL. Primary endpoints included safety and weight change from baseline to week Secondary endpoints included changes in waist circumference, blood pressure, lipids, glycemic control, and metabolic syndrome.

Three subjects could not be implanted due to short duodenal bulb. There were no procedure-related complications and there were 15 early endoscopic removals. In the week completer population, total body weight change from baseline was There were also significant improvements in waist circumference, blood pressure, total and low-density lipoprotein cholesterol, triglycerides, and fasting glucose. The authors concluded that the DJBL is safe when implanted for 1 year, and results in significant weight loss and improvements in cardio-metabolic risk factors.

They stated that these results suggested that this device may be suitable for the treatment of morbid obesity and its related comorbidities.

Verdam et al stated that the prevalence of obesity is increasing worldwide. Its primary treatment consists of lifestyle changes. Operations such as the placement of a gastric band or a gastric bypass can, however, lead to complications and necessitate secondary interventions. In search of less invasive treatments, placement of the EndoBarrier duodenal jejunal bypass liner appears to be a promising, safe and effective method for facilitating weight loss. Concomitant positive effects on cardiovascular risk factors including diabetes type 2 were observed.

The authors noted that a multi-center trial is currently underway to examine the mechanism behind these effects. Mathus-Vliegen stated that the EndoBarrier is a unique concept that starts to ameliorate the symptoms of diabetes mellitus type 2, soon after positioning. Sufficient implant training is required, but problems can still occur e. The stability of the anchors and the tolerability of the device still leave much to be desired. Only 7 studies on the EndoBarrier are available and these are mostly small in size, short-term and with limited follow-up, and many questions regarding the safety and long-term effects of the device remain.

The author concluded that this calls for a large, long-term, randomized, placebo-controlled, double-blind trial. Lessons should have been learned from the disastrous results with intra-gastric balloon implantation before commercializing another such product. Bolton et al stated that weight regain secondary to VBG pouch dilation is a typical referral for bariatric surgeons.

A retrospective review was completed for patients with a previous VBG presenting with weight regain between to The median length of stay following RYGB was 6 days compared to 1.

The authors concluded that the findings of this study suggested that while RYGB revision may achieve greater weight loss, the complication rates and severity is discouraging.

StomaphyX may be a safe alternative. Moreover, they stated that further technical modifications of the device and longer follow-up may clarify the role of this approach.

Goyal et al examined if endoluminal reduction of gastric pouch and stoma using StomaphyX results in sustained weight loss in patients who regain weight after gastric bypass.

Retrospective chart review was performed on 59 post-gastric bypass patients who underwent revision of gastric pouch using StomaphyX from to Post-procedure weight at 1 week, 1 month, and 6 months follow-up as well as weight at the time of the review was recorded for each patient.

Average weight loss and excess body weight loss EBWL were 2. At the time of review, the average follow-up was 41 months, average weight loss was 1. Endoscopy in 12 patients at average 18 months follow-up showed no sustained reduction in pouch and stoma size.

The authors concluded that StomaphyX resulted in weight loss that is not sustained on long-term follow-up. Pouch and stoma tend to regain their pre-procedure size on follow-up. They stated that StomaphyX cannot be recommended as a weight loss strategy in post-gastric bypass patients who regain weight. There is currently no well-defined management protocol for this complication. Through systematic review, these investigators analyzed the results of endoscopic dilation in patients with stenosis, including complication and success rates.

The PubMed database was searched for relevant studies published each year from to , and 23 studies were identified for analysis. Only papers describing the treatment of anastomotic stricture after RYGB were included, and case-reports featuring less than 3 patients were excluded. The mean age of the trial populations was Through-the-scope balloons were used in 16 studies Other complications were also reported: 1 esophageal hematoma, 1 Mallory-Weiss tear, 1 case of severe nausea and vomiting, and 2 cases of severe abdominal pain.

The authors concluded that endoscopic treatment of stenosis is safe and effective; however, further high-quality randomized controlled trials are needed to confirm these findings. Thompson et al stated that weight regain or insufficient loss after RYGB is common.

This is partially attributable to dilatation of the gastro-jejunostomy, which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery.

These researchers performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction TORe. Intra-operative performance, safety, weight loss, and clinical outcomes were assessed. Subjects who received TORe had a significantly greater mean percentage weight loss from baseline 3.

As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls 3. The groups had similar frequencies of adverse events. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices.

These researchers stated that TORe is one approach to avoid weight regain; moreover, they noted that a longitudinal multi-disciplinary approach with dietary counseling and behavioral changes are needed for long-term results.

Jirapinyo et al evaluated the technical feasibility, safety, and early outcomes of a procedure using a commercially available endoscopic suturing device to reduce the diameter of the GJA. An endoscopic suturing device was used to place sutures at the margin of the GJA in order to reduce its aperture. On chart review, clinical data were available at 3, 6, and 12 months. Average anastomosis diameter was The mean weight loss in successful cases was There were no major complications.

The authors concluded that this case series demonstrated the technical feasibility, safety, and effectiveness of performing GJ reduction using a commercially available endoscopic suturing device. They stated that this technique may represent an effective and minimally invasive option for the management of weight regain in patients with RYGB. Dakin and colleagues noted that weight recidivism after RYGB is a challenging problem for patients and bariatric surgeons alike.

Traditional operative strategies to combat weight regain are technically challenging and associated with a high morbidity rate. Endoluminal interventions are thus an attractive alternative that may offer a good combination of results coupled with lower peri-procedure risk that might one day provide a solution to this increasingly prevalent problem.

These investigators systematically reviewed the available literature on endoluminal procedures used to address weight regain after RYGB, with specific attention to the safety profile, effectiveness, cost, and current availability. This retrospective review focused only on endoluminal procedures that were performed for weight regain after RYGB, as opposed to primary endoluminal obesity procedures. Several methods of endoluminal intervention for weight regain were reviewed, ranging from injection of inert substances to suturing and clipping devices.

The literature review showed the procedures on the whole to be well-tolerated with limited effectiveness. The majority of the literature was limited to small case-series. Most of the reviewed devices were no longer commercially available. The authors concluded that endoluminal therapy represents an intriguing strategy for weight regain after RYGB. However, the current and future technologies must be rigorously studied and improved such that they offer durable, repeatable, cost-effective solutions.

Pauli et al stated that despite advances in many areas of therapeutic endoscopy, the development of an effective endoscopic suturing device has been elusive.

These researchers evaluated the safety and effectiveness of a suturing device to place and secure sutures within normal, in-vivo human colonic tissue prior to surgical resection.

Patients undergoing elective colectomy were enrolled in this treat-and-resect model. The OverStitch endoscopic suturing device Apollo Endosurgery, Austin, TX was used to place sutures in healthy colonic tissue during a min, time-limited period.

Clinical and operative data were recorded. Seven sutures were successfully placed, incorporating a total of 10 tissue bites in a mean of On inspection of the explanted tissue, all sutures were found to be located sub-serosal no full thickness bites were taken.

The suture and cinch elements were judged to be effective in the majority of cases. One device-related issue did not inhibit the ability to oppose tissue or place the cinch. There were no intra-operative or post-operative complications. The authors concluded that the OverStitch permitted safe and effective suturing in an in-vivo human colon model. The sutures were placed at a consistent sub-serosal depth and at no point risked iatrogenic injury to adjacent structures.

Technical issues with the device were infrequent and did not inhibit the ability to place sutures effectively. This clinical trial is designed to study the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient.

The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient. A total of 22 obese patients mean age of After dissecting the greater omentum and short gastric vessels, the gastric greater curvature plication with 2 rows of non-absorbable suture was performed under the guidance of a F bougie.

The data were collected during follow-up examinations performed at 1, 3, 6, and 12 months post-operatively. All procedures were performed laparoscopically. The mean operative time was There were no deaths or post-operative major complications that needed re-operation. Decreases in the index for homeostasis model assessment of insulin resistance HOMA-IR and in insulin and glucose concentrations were observed. The authors concluded that the early outcomes of LGCP as a novel treatment for obese Chinese with a relatively low BMI were satisfactory with respect to the effectiveness and low incidence of major complications.

They stated that additional long-term follow-up and prospective, comparative trials are still needed. In a pilot study, Legner et al examined the effectiveness of transoral mucosal excision sutured gastroplasty for the treatment of gastro-esophageal reflux disease GERD and obesity. Obese patients BMI greater than 35 underwent a psychological evaluation and tests for co-morbidities.

Under general anesthesia, a procedure was performed at the gastro-esophageal junction including mucosal excision, suturing of the excision beds for apposition, and suture knotting. One patient with micrognathia could not undergo the required pre-procedural passage of a 60 F dilator and was excluded. The first 2 GERD patients had incomplete procedures due to instrument malfunction.

The subsequent 5 subjects had a successfully completed procedure. Four patients were treated for obesity and had an average excess weight loss of Of these patients, 1 had an 8-mm outlet at the end of the procedure recognized on video review — a correctable error — and another vomited multiple times post-operatively and loosened the gastroplasty sutures.

The treated GERD patient had resolution of reflux-related symptoms and is off all anti-secretory medications at 2-year follow-up. Her DeMeester score was 8. The authors concluded that the initial human clinical experience showed promising results for effective and safe GERD and obesity therapy. Georgiadou et al summarized the available evidence about the efficacy and safety of laparoscopic mini-gastric bypass LMGB. These investigators performed a systematic search in the literature, and PubMed and reference lists were scrutinized end-of-search date: July 15, For the assessment of the eligible articles, the Newcastle-Ottawa quality assessment scale was used.

A total of 10 eligible studies were included in this study, reporting data on 4, patients. Moreover, resolution or improvement in all major associated medical illnesses and improvement in overall Gastrointestinal Quality of Life Index score were recorded. Major bleeding and anastomotic ulcer were the most commonly reported complications. The latter were conducted due to a variety of medical reasons such as inadequate or excessive weight loss, malnutrition, and upper gastro-intestinal bleeding.

The authors concluded that LMGB represents an effective bariatric procedure; its safety and minimal post-operative morbidity seem remarkable. They stated that randomized comparative studies seem mandatory for the further evaluation of LMGB. These researchers included 10 studies with a total of patients that primarily investigated a prototype of the DJBL.

In high-grade obese patients, short-term excess weight loss was observed. For the remaining patient-relevant endpoints and patient populations, evidence was either not available or ambiguous. The authors do not yet recommend the device for routine use. Parikh et al compared bariatric surgery versus intensive medical weight management MWM in patients with type 2 diabetes mellitus T2DM who do not meet current National Institutes of Health criteria for bariatric surgery and examined if the soluble form of receptor for advanced glycation end products sRAGE is a biomarker to identify patients most likely to benefit from surgery.

A total of 57 patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery bypass, sleeve or band, based on patient preference. The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance HOMA-IR and diabetes remission. The surgery group lost more weight 7. There were no mortalities. Baseline sRAGE may predict patients most likely to benefit from surgery.

However, they stated that these findings need to be confirmed with larger studies. Sjostrom et al noted that short-term studies showed that bariatric surgery causes remission of diabetes. The long-term outcomes for remission and diabetes-related complications are not known. These researchers determined the long-term diabetes remission rates and the cumulative incidence of microvascular and macrovascular diabetes complications after bariatric surgery.

The Swedish Obese Subjects SOS is a prospective matched cohort study conducted at 25 surgical departments and primary health care centers in Sweden. Of patients recruited between September 1, , and January 31, , of 2, control patients and of 2, surgery patients had type-2 diabetes at baseline.

For the current analysis, diabetes status was determined at SOS health examinations until May 22, Information on diabetes complications was obtained from national health registers until December 31, For diabetes assessment, the median follow-up time was 10 years interquartile range [IQR], 2 to 15 and 10 years IQR, 10 to 15 in the control and surgery groups, respectively.

For diabetes complications, the median follow-up time was Main outcome measures were diabetes remission, relapse, and diabetes complications. The diabetes remission rate 2 years after surgery was At 15 years, the diabetes remission rates decreased to 6.

With long-term follow-up, the cumulative incidence of microvascular complications was Macrovascular complications were observed in The authors concluded that in this very long-term follow-up observational study of obese patients with type 2 diabetes, bariatric surgery was associated with more frequent diabetes remission and fewer complications than usual care.

Moreover, they stated that these findings require confirmation in randomized trials. Yu et al evaluated the long-term effects of bariatric surgery on type 2 diabetic patients. These investigators searched Cochrane Library, PubMed, and EMbase up to Dec ; RCTs and cohort studies of bariatric surgery for diabetes patients that reported data with more than 2 years of follow-up were included.

They used rigorous methods to screen studies for eligibility and collected data using standardized forms. Where applicable, these investigators pooled data by meta-analyses. A total of 26 studies, including 2 RCTs and 24 cohort studies that enrolled 7, patients, proved eligible. Despite the differences in the design, those studies consistently showed that bariatric surgery offered better treatment outcomes than non-surgical options.

Pooling of cohort studies showed that BMI decreased by The process the team uses to determine if you're ready for weight-loss surgery is also there to help you make an informed decision. You will need to consider the benefits and risks, follow through with pre-surgery and post-surgery plans, and make a lifelong commitment to a new nutrition and exercise program.

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See more conditions. Healthy Lifestyle Weight loss. Products and services. Weight-loss surgery: Is it an option for you? Learn about the criteria you must meet to have weight-loss surgery. By Mayo Clinic Staff. Thank you for Subscribing Our Housecall e-newsletter will keep you up-to-date on the latest health information. Find general guidelines for fluids, protein and more here. The UCSF Bariatric Surgery Center offers comprehensive follow-up care, including a support group, dietitian and education to help you achieve long-term success.

Patients spend an average of two to five days in the hospital following bariatric surgery, or longer if complications develop.

Learn more here. Bariatric Surgery. Patient Education. Bariatric Surgery Requirements To be eligible for weight-loss surgery , you must meet the following requirements: Have a body mass index BMI of 40 or higher, or have a BMI between 35 and 40 and an obesity-related condition, such as heart disease, diabetes, high blood pressure or severe sleep apnea. Weigh less than pounds, the maximum weight that hospital radiology equipment can accommodate. If you need to lose weight to meet this requirement, a nutritionist is available to help.

Lap Band Complications October 3, Mini-Gastric Bypass. Am I Morbidly Obese? Insurance and Costs Pre-approval Process Resources. The list below is organized by insurance company. We include the following important information for each insurance company listed: Which weight loss surgeries are covered. Required criteria before gastric bypass, Lap Band or other procedures are approved for coverage.

If Lap Band fills are covered after surgery. Contact information for your insurance provider.