NCT04994665Recruiting
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Source: ClinicalTrials.gov · Last updated 23 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 526 (estimated)
- First submitted
- 29 Jul 2021
- Start date
- 7 Dec 2021
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Diseases
- Obesity
- NCT number
- NCT04994665
What you commit to
- Study type: Interventional
- Planned participants: 526
- From 7 Dec 2021 to the primary completion date, 1 Nov 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Eating disorder or mental disorder
- Psychiatric contraindication
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH de la côte Basque Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Recruiting |
| Centre Hospitalier Emile Roux Coordinator of this site? Confirm its status | Le Puy-en-Velay | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Clinique Jules Verne Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Régional et Universitaire d'Orléans Coordinator of this site? Confirm its status | Orléans | France | Recruiting |
| Hôpital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Clinique Mutualiste de la Sagesse Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| Clinique Santé Atlantique Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.