Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass

Study Overview
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Brief Summary
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It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating. For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass. The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.

Official Title
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Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery

Conditions
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Obesity

Intervention / Treatment
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* Device: Transoral Suturing
* Other: Sham Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 months post primary RYGB with inadequate weight loss or weight regain BMI >30 and ≤ 50 Dilated gastrojejunal anastomosis Successfully completes screening process Signed consent Exclusion Criteria: Recently quit smoking or plan to quit within the next year Pregnant or planning to become pregnant over the course of the next 9 months Mallampati score of 4 Serious systemic disease or active disease of the gastrointestinal tract Gastric pouch abnormalities Significant movement limitations Use of weight-promoting or weight-reduction drugs during study period Severe eating disorders Uncontrolled depression or psychoses Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure History of significant cardiovascular, cerebrovascular or pulmonary disease Not a candidate for conscious or general sedation Anticoagulant therapies Active substance abuse Life expectancy < 1 year Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Transoral suturing of the dilated gastrojejunostomy | Device: Transoral Suturing<br>* suturing of anastomosis<br>|
| Sham Comparator: 2<br>Sham Endoscopy (suturing not performed) | Other: Sham Endoscopy<br>* suturing not performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss (%) | Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Achieving 15% Excess Weight Loss (EWL) | %Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100. | 6 months | 
| Subjects Achieving Weight Stabilization at 6 Months | Weight is stabilized if 6 month weight is +/- 2% from baseline weight. | 6 months | 
| Subjects Achieving 20% Excess Weight Loss at 6 Months | %Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Transoral Suturing, Dilated gastrojejunostomy, Inadequate weight loss following primary RYGB