Evaluating the effect of omentopexy on reflux after sleeve gastrectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the impact of omentopexy on the development of gastro-oesophageal reflux disease (GERD) following sleeve gastrectomy. It is a prospective, multicentric, randomized trial involving 526 patients, divided into two groups: one undergoing sleeve gastrectomy alone and the other undergoing sleeve gastrectomy with omentopexy. The evaluation will occur two years post-surgery, utilizing the CARLSSON and BAROS scores to measure quality of life and reflux rates. The primary goal is to demonstrate that omentopexy reduces the incidence of de novo GERD without relying on Proton-Pump Inhibitors.

Why it matters

Who can join: the full rules

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

Where it's running

• CH de la Cote Basque
  Bayonne, France Recruiting
• CHD Vendée
  La Roche-sur-Yon, France Recruiting
• Centre Hospitalier Emile Roux
  Le Puy-en-Velay, France Recruiting
• CHU Nantes
  Nantes, France Recruiting
• Clinique Jules Verne
  Nantes, France Recruiting
• Centre Hospitalier Régional et Universitaire d'Orléans
  Orléans, France Recruiting

Study contacts

• Principal investigator: Emeric Abet, Dr — CHD Vendée
• Study coordinator: Agnès Dorion
• Email: agnes.dorion@chd-vendee.fr
• Phone: 251446380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.