Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 526
- 试验地点
- 18
- 主要终点
- Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
研究概览
简要总结
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.
This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.
Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).
The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)
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
- Single (Participant)
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
- •Patient ≥ 18 years old,
- •Patient to be operated in first intention of a sleeve gastrectomy
- •Initial BMI between 35Kg/m² and 40 Kg/m² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.
- •OR initial BMI ≥ 40 Kg/m².
- •Multidisciplinary follow-up of at least 6 months before surgery
- •Validation of the surgical intervention in a multidisciplinary consultation meeting
- •Certificate of no contraindication by a psychiatrist
- •Patient who has the capacity to understand the protocol and has given consent to participate in the research,
- •Patient with social security coverage.
排除标准
- •Eating disorder or mental disorder
- •Misunderstanding of the protocol
- •Psychiatric contraindication
- •Initial BMI <35Kg/m².
- •Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
- •Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy
- •CARLSSON score (score ≥ 4) preoperatively
- •Presence of a Proton-Pump Inhibitors treatment
- •Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)
- •Patient participating in another interventional clinical research protocol involving a drug or medical device
- •Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery
- •Patient under guardianship, curators or legal protection,P
结局指标
主要结局
Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
时间窗: 2 years postoperatively
Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment
次要结局
未报告次要终点