NCT00411489已完成不适用
Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
USGI Medical6 个研究点 分布在 1 个国家开始时间: 2006年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 6
- 主要终点
- weight loss
研究概览
简要总结
The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 yrs of age or older and < 65 yrs of age
- •At least 2 yrs post-Roux-En-Y gastric bypass surgery
- •Initially achieved at least 50% weight loss
- •At enrollment, has regain at least 15% of weight loss
- •BMI 40 or greater or 35 or greater with one or more co-morbidities
- •Stoma diameter at least 20 mm
- •Completes successful nutritional screening
- •Is a candidate for a surgical revision procedure
- •Is a reasonable risk to undergo general anesthesia
- •Completes successful cardiopulmonary evaluation
- •ASA Classification of less than or equal to III
- •Able to provide written consent
- •Able to return for protocol-specified evaluations
排除标准
- •Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
- •Previous bariatric revision procedure
- •Has another causal factor for weight regain other than stoma or pouch dilatation
- •Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program
结局指标
主要结局
weight loss
次要结局
未报告次要终点
研究者
研究点 (6)
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