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Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Sponsor: Centre Hospitalier Departemental Vendee
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
526
Start Date
2021-12-07
Completion Date
2028-11-01
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
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
Locations (9)
CH de la Cote Basque
Bayonne, France
CHD Vendée
La Roche-sur-Yon, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
CHU Nantes
Nantes, France
Clinique Jules Verne
Nantes, France
Centre Hospitalier Régional et Universitaire d'Orléans
Orléans, France
Hopital Pontchaillou
Rennes, France
Clinique Mutualiste de la Sagesse
Rennes, France
Clinique Santé Atlantique
Saint-Herblain, France