The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Occurence of gastroesophageal reflux disease
研究概览
简要总结
Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.
详细描述
This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indications for bariatric surgery (BMI over 40Kg/m2 or over 35Kg/m2 associated to a life-treating morbid conditions.
- •Acceptance to be submitted to a 24h pH-monitoring and esophageal manometry
- •No contra-indication for gastric bypass
- •Absence of previous gastric surgery
- •Option for open gastric bypass
排除标准
- •Inferior and superior total teeth prosthesis
- •Poor surgical conditions
结局指标
主要结局
Occurence of gastroesophageal reflux disease
时间窗: march 2010 to march 2014
Patients are intra-operatively selected to receive or not a silastic ring following a open gastric bypass. These patients will be evaluated for GERD with upper endoscopy, 24h ph-monitoring, validated questionnaires which will be performed at 6 month, 1 and 2 years.
次要结局
- The role of the ring in open GBP in terms of weight loss(march 2010 to march 2014)
- The impact of the ring on food tolerance(March 2010 to March 2014)
研究者
Carlos AS Madalosso
Carlos AS Madalosso
Clinica Gastrobese