Tests omentopexy to reduce reflux after sleeve gastrectomy in people with obesity
Tests adding omentopexy to sleeve gastrectomy in adults with obesity, looking at reflux.
Plain-language title generated from the registry record
Registry title: Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Key facts
- Where
- Bayonne, La Roche-sur-Yon, Le Puy-en-Velay, Nantes, Orléans, Rennes, and Saint-Herblain, FranceSee the 9 sites
Where in France
- CH de la côte BasqueBayonne, FranceTaking people
- CHD VendéeLa Roche-sur-Yon, FranceTaking people
- Centre Hospitalier Emile RouxLe Puy-en-Velay, FranceTaking people
- CHU NantesNantes, FranceTaking people
- Clinique Jules VerneNantes, FranceTaking people
- Centre Hospitalier Régional et Universitaire d'OrléansOrléans, FranceTaking people
- Clinique Mutualiste de la SagesseRennes, FranceNot yet recruiting
- Hôpital PontchaillouRennes, FranceTaking people
- Clinique Santé AtlantiqueSaint-Herblain, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Departemental Vendee
- Trial code
- NCT04994665
- Record updated
- 23 September 2025
- Original description
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.Read full original descriptionShow less
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
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)
Inclusion: 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.
Exclusion: 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; Eating disorder or mental disorder; Psychiatric contraindication; Misunderstanding of the protocol; 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; Patient under guardianship, curators or legal protection,P.