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NCT Number: NCT04994665

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de la Cote Basque, Bayonne, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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

Treatment and study plan

Sleeve gastrectomy

Procedure

The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed

sleeve gastrectomy with omentopexy

Procedure

After 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

Primary outcomes

  1. Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone

    Time frame: 2 years postoperatively

    Presence of de novo GERD defined by a clinical score of CARLSSON >= 4 and/or the use of a PPIs treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Agnès Dorion

CONTACT

[email protected]

251446380 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: Sleevepexie

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2021
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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