Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Recruiting now · Not applicable

Conditions studied: Obesity

In brief

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 facts

Study ID

NCT04994665

Run by

Centre Hospitalier Departemental Vendee

People needed

526

Starts

2021-12-07

Expected to finish

2028-11-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient ≥ 18 years old,
• Patient to be operated in first intention of a sleeve gastrectomy
• Initial BMI between 35Kg/m² and 40 Kg/m² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.
• OR initial BMI ≥ 40 Kg/m².
• Multidisciplinary follow-up of at least 6 months before surgery
• Validation of the surgical intervention in a multidisciplinary consultation meeting
• Certificate of no contraindication by a psychiatrist
• Patient who has the capacity to understand the protocol and has given consent to participate in the research,
• Patient with social security coverage.

You may not qualify if…

• Eating disorder or mental disorder
• Misunderstanding of the protocol
• Psychiatric contraindication
• Initial BMI <35Kg/m².
• Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
• Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy
• CARLSSON score (score ≥ 4) preoperatively
• Presence of a Proton-Pump Inhibitors treatment
• Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)
• Patient participating in another interventional clinical research protocol involving a drug or medical device
• Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery
• Patient under guardianship, curators or legal protection,P

Where it is running

• Clinique Santé Atlantique — Saint-Herblain, France (enrolling)
• CHD Vendée — La Roche-sur-Yon, France (enrolling)
• Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (enrolling)
• CHU Nantes — Nantes, France (enrolling)
• Clinique Jules Verne — Nantes, France (enrolling)
• Centre Hospitalier Régional et Universitaire d'Orléans — Orléans, France (enrolling)
• Hopital Pontchaillou — Rennes, France (enrolling)
• CH de la Cote Basque — Bayonne, France (enrolling)
• Clinique Mutualiste de la Sagesse — Rennes, France

Full record on ClinicalTrials.gov

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