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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
526
The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
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
CH de la Cote Basque
Bayonne, France
RECRUITINGCHD Vendée
La Roche-sur-Yon, France
RECRUITINGCentre Hospitalier Emile Roux
Le Puy-en-Velay, France
RECRUITINGCHU Nantes
Nantes, France
RECRUITINGClinique Jules Verne
Nantes, France
RECRUITINGCentre Hospitalier Régional et Universitaire d'Orléans
Orléans, France
RECRUITINGHopital Pontchaillou
Rennes, France
RECRUITINGClinique Mutualiste de la Sagesse
Rennes, France
NOT_YET_RECRUITINGClinique Santé Atlantique
Saint-Herblain, France
RECRUITINGEvaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment
Time frame: 2 years postoperatively
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