Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Last updated: June 5, 2024
Sponsor: Centre Hospitalier Departemental Vendee
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Gastroesophageal Reflux Disease (Gerd)

Treatment

sleeve gastrectomy with omentopexy

sleeve gastrectomy

Clinical Study ID

NCT04994665
CHD21-0032
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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-relatedcomorbidity (hypertension, obstructive sleep apnea syndrome, type II diabetes, earlyosteoarthritis 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 toparticipate in the research,

  • Patient with social security coverage.

Exclusion

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 orSingle Anastomosis Duodeno-Ileal bypass)

  • Patient participating in another interventional clinical research protocol involvinga drug or medical device

  • Patient who are pregnant, breastfeeding, or who have the potential to becomepregnant without effective contraception at the time of inclusion and up to 24months after surgery

  • Patient under guardianship, curators or legal protection,P

Study Design

Total Participants: 526
Treatment Group(s): 2
Primary Treatment: sleeve gastrectomy with omentopexy
Phase:
Study Start date:
December 07, 2021
Estimated Completion Date:
November 01, 2028

Connect with a study center

  • CH de la Cote Basque

    Bayonne,
    France

    Active - Recruiting

  • CHD Vendée

    La Roche sur Yon, 85000
    France

    Active - Recruiting

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay, 43012
    France

    Active - Recruiting

  • CHU Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • Clinique Jules Verne

    Nantes, 44300
    France

    Active - Recruiting

  • Centre Hospitalier Régional et Universitaire d'Orléans

    Orléans,
    France

    Active - Recruiting

  • Clinique Mutualiste de la Sagesse

    Rennes,
    France

    Site Not Available

  • Hopital Pontchaillou

    Rennes, 35000
    France

    Active - Recruiting

  • Clinique Santé Atlantique

    Saint-Herblain, 44800
    France

    Active - Recruiting

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