Clinical Trial

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Study acronym: Sleevepexie
Recruiting
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Summary
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)
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-07-29; most recent amendment 2025-09-18.
Status change: Not Yet Recruiting → Recruiting 2021-12-14
Trial Details
NCT Number NCT04994665
Lead Sponsor Centre Hospitalier Departemental Vendee
Conditions Obesity
Enrollment 526 participants
Start Date 2021-12-07
Primary Completion 2027-11-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-23