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RECRUITING
NCT04994665
NA

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Sponsor: Centre Hospitalier Departemental Vendee

View on ClinicalTrials.gov

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

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

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