Clinical trial
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Recruiting now · Not applicable · 1 countries · Registry ID NCT04994665
What this study is about
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)
Basic eligibility
Full registry criteria
Treatments and study arms
sleeve gastrectomy
The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
sleeve gastrectomy with omentopexy
After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature
Primary outcomes
Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment
Study locations
9 locations were listed when this page was built. The first 40 are shown.