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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
sleeve gastrectomy
Procedure/SurgeryThe sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
sleeve gastrectomy with omentopexy
Procedure/SurgeryAfter sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature
Treatment groups
526 Participants
are divided into 2 treatment groupsGroup A: Sleeve gastrectomyActive comparator 1 intervention
Group B: sleeve gastrectomy with omentopexyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment
Time frame
2 years postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov