NCT04994665

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 526 (estimated)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	sleeve gastrectomy	The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
PROCEDURE	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

Timeline

• Start date: 2021-12-07
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2021-08-06
• Last updated: 2025-09-23

Locations

9 sites across 1 country: France