Actively Recruiting
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Led by Centre Hospitalier Departemental Vendee · Updated on 2025-09-23
526
Participants Needed
9
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years old or older
- Planned first sleeve gastrectomy surgery
- Initial BMI between 35 and 40 with at least one severe comorbidity likely to improve after surgery or initial BMI 40 or higher
- Multidisciplinary medical follow-up for at least 6 months before surgery
- Surgical intervention approved in a multidisciplinary consultation
- Certificate of no psychiatric contraindication
- Ability to understand the study and provide consent
- Covered by social security
You will not qualify if you...
- Eating or mental disorders
- Unable to understand the study protocol
- Psychiatric contraindications
- Initial BMI less than 35
- Initial BMI between 35 and 40 without comorbidities
- Esophagitis grade B or higher on endoscopy
- Preoperative CARLSSON score of 4 or more
- Current use of proton-pump inhibitors
- Planned two-stage surgery (sleeve gastrectomy followed by gastric bypass or other bypass)
- Participation in another interventional clinical trial involving drugs or devices
- Pregnant, breastfeeding, or potential pregnancy without effective contraception during study and 24 months after surgery
- Under legal guardianship, curatorship, or legal protection
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Trial Site Locations
Total: 9 locations
1
CH de la Cote Basque
Bayonne, France
Actively Recruiting
2
CHD Vendée
La Roche-sur-Yon, France, 85000
Actively Recruiting
3
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France, 43012
Actively Recruiting
4
CHU Nantes
Nantes, France, 44000
Actively Recruiting
5
Clinique Jules Verne
Nantes, France, 44300
Actively Recruiting
6
Centre Hospitalier Régional et Universitaire d'Orléans
Orléans, France
Actively Recruiting
7
Hopital Pontchaillou
Rennes, France, 35000
Actively Recruiting
8
Clinique Mutualiste de la Sagesse
Rennes, France
Not Yet Recruiting
9
Clinique Santé Atlantique
Saint-Herblain, France, 44800
Actively Recruiting
Research Team
A
Agnès Dorion
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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