Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CH de la Cote Basque
RECRUITING
Bayonne
CHD Vendée
RECRUITING
La Roche-sur-yon
Centre Hospitalier Emile Roux
RECRUITING
Le Puy-en-velay
CHU Nantes
RECRUITING
Nantes
Clinique Jules Verne
RECRUITING
Nantes
Centre Hospitalier Régional et Universitaire d'Orléans
RECRUITING
Orléans
Clinique Mutualiste de la Sagesse
NOT_YET_RECRUITING
Rennes
Hopital Pontchaillou
RECRUITING
Rennes
Clinique Santé Atlantique
RECRUITING
Saint-herblain
Contact Information
Primary
Agnès Dorion
agnes.dorion@chd-vendee.fr
251446380
Time Frame
Start Date: 2021-12-07
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 526
Treatments
Active_comparator: Sleeve gastrectomy
realization of a sleeve gastrectomy alone
Experimental: sleeve gastrectomy with omentopexy
realization of a sleeve gastrectomy followed by an omentopexy
Sponsors
Leads: Centre Hospitalier Departemental Vendee

This content was sourced from clinicaltrials.gov