Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy (Sleevepexie)

  • STATUS
    Recruiting
  • End date
    Nov 1, 2026
  • participants needed
    526
  • sponsor
    Centre Hospitalier Departemental Vendee
Updated on 21 March 2022
diabetes
hypertension
dyslipidemia
sleeve gastrectomy

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)

Details
Condition Obesity
Treatment sleeve gastrectomy, sleeve gastrectomy with omentopexy
Clinical Study IdentifierNCT04994665
SponsorCentre Hospitalier Departemental Vendee
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 an obesity-related comorbidity (hypertension, obstructive sleep apnea syndrome, type II diabetes, early osteoarthritis authenticated by a rheumatologist or an orthopedist, dyslipidemia, hepatic steatosis) 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

Exclusion Criteria

Eating disorder or mental disorder
Misunderstanding of the protocol
Psychiatric contraindication
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
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
Patient under guardianship, curators or legal protection,P
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