Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 77
- 试验地点
- 10
- 主要终点
- Weight Loss (%)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Transoral suturing of the dilated gastrojejunostomy
干预措施: Transoral Suturing (Device)
2
Sham Endoscopy (suturing not performed)
干预措施: Sham Endoscopy (Other)
结局指标
主要结局
Weight Loss (%)
时间窗: 6 months
Percent Weight Loss is computed as \[(Baseline weight - 6 mo. weight) / Baseline weight\] \* 100
次要结局
- Subjects Achieving Weight Stabilization at 6 Months(6 months)
- Subjects Achieving 15% Excess Weight Loss (EWL)(6 months)
- Subjects Achieving 20% Excess Weight Loss at 6 Months(6 months)