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Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Departemental Vendee
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • sleeve gastrectomy
  • sleeve gastrectomy with omentopexy
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Where

9 sites
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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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