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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

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CH de la côte Basque
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BayonneFranceRecruiting
CHD Vendée
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La Roche-sur-YonFranceRecruiting
Centre Hospitalier Emile Roux
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Le Puy-en-VelayFranceRecruiting
CHU Nantes
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NantesFranceRecruiting
Clinique Jules Verne
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NantesFranceRecruiting
Centre Hospitalier Régional et Universitaire d'Orléans
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OrléansFranceRecruiting
Hôpital Pontchaillou
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RennesFranceRecruiting
Clinique Mutualiste de la Sagesse
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RennesFranceNot yet recruiting
Clinique Santé Atlantique
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Saint-HerblainFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.