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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
77
suturing of anastomosis
suturing not performed
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Lebanon, New Hampshire, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Milwaukee, Wisconsin, United States
Weight Loss (%)
Percent Weight Loss is computed as \[(Baseline weight - 6 mo. weight) / Baseline weight\] \* 100
Time frame: 6 months
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.
Time frame: 6 months
Subjects Achieving Weight Stabilization at 6 Months
Weight is stabilized if 6 month weight is +/- 2% from baseline weight.
Time frame: 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
Time frame: 6 months
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