Evaluation of Post-Omega Bypass Excluded Stomach Fundoplication to Treat Disabling Gastroesophageal Reflux Disease Resistant to Medical Treatment and Requiring Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Response rate after Fundoplicature with stomach excluded
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of fundoplication with stomach excluded in the suppression of disabling gastroesophageal reflux requiring surgery in patients who have undergone one anastomosis gastric bypass, with complete objective evaluation of reflux.
详细描述
The FEE& RGOIC trial is a single-center, ambispective, interventional, non-randomized pilot study to evaluate the efficacy of Fundoplicature with stomach excluded objectively and comprehensively in the treatment of disabling gastroesophageal reflux requiring gastric bypass after anastomosis.
The strategy under study is objective reflux suppression after fundoplication with the stomach excluded in the following specific context: treatment of disabling gastroesophageal reflux requiring post-bypass surgery in Omega.
The eligible study population will be any adult patient at the investigating center who has undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach as part of treatment for disabling post-bypass gastro-oesophageal reflux, resistant to medical treatment and requiring surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Single-center, ambispective, interventional, non-randomized pilot study
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
- •Age ≥ 18 years;
- •Patient operated for one anastomosis gastric bypass followed by Fundoplicature with stomach excluded for disabling gastroesophageal reflux requiring surgery within 2 years prior to inclusion;
- •Patient in failure of medical treatment;
- •Weight loss greater than 50% of excess weight;
- •Patient with preoperative objective investigations (gastrojejunal fibroscopy, ph-impedancemetry, abdominal CT scan) of gastroesophageal reflux disease;
- •Patient able to understand study-related information and to complete quality-of-life questionnaires in the opinion of the investigator;
- •Patient willing to accept study evaluations;
- •For women of childbearing age, effective contraception for the duration of the study or negative blood pregnancy test;
- •Patient has been informed and has given free, informed and written consent.
排除标准
- •Patient with conversion from one anastomosis gastric bypass to Y bypass for disabling gastroesophageal reflux requiring surgery;
- •Patient with concomitant hiatal hernia correction for one anastomosis gastric bypass ;
- •Patient with secondary one anastomosis gastric bypass ;
- •Patient with a deregulated diet;
- •Patient under legal protection, or deprived of liberty by judicial or administrative decision;
- •Patient unable to understand study information for linguistic, psychological, cognitive or other reasons;
- •Women who are or may become pregnant, of childbearing age, without effective contraception or who are breast-feeding;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial that could interfere with the results of the present study;
- •Patient not covered by a social security scheme.
研究组 & 干预措施
Gastroesophageal reflux disease
Disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgery
干预措施: Bypass surgery type one anastomosis gastric bypass (Procedure)
结局指标
主要结局
Response rate after Fundoplicature with stomach excluded
时间窗: 2 years
The primary endpoint is the long-term efficacy of Fundoplicature with stomach excluded in the treatment of disabling Gastroesophageal Reflux Disease requiring Omega post-bypass surgery after surgery.
次要结局
未报告次要终点