Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Departemental Vendee
About this trial
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)
Eligibility criteria
Qualifiers
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.
Multidisciplinary follow-up of at least 6 months before surgery
Disqualifiers
Eating disorder or mental disorder
Misunderstanding of the protocol
Psychiatric contraindication
Initial BMI <35Kg/m².
Trial design
Treatments tested in this trial
- sleeve gastrectomy
- sleeve gastrectomy with omentopexy
Treatment groups
526 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov