Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

NCT04994665 | Recruiting

• 1 other identifier: CHD21_0032
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 9

Brief 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)

Conditions

Obesity

Keywords

sleeve gastrectomy; omentopexy; gastro-oesophageal disease

Outcome Measures

Primary Outcomes (1)

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

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

  2 years postoperatively

Study Arms (2)

Sleeve gastrectomy

ACTIVE COMPARATOR

realization of a sleeve gastrectomy alone

Procedure: sleeve gastrectomy

sleeve gastrectomy with omentopexy

EXPERIMENTAL

realization of a sleeve gastrectomy followed by an omentopexy

Procedure: sleeve gastrectomy with omentopexy

Interventions

sleeve gastrectomy PROCEDURE

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

Sleeve gastrectomy

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

sleeve gastrectomy with omentopexy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under guardianship, curators or legal protection,P

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (9)

CH de la Cote Basque

Bayonne, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85000, France

RECRUITING

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43012, France

RECRUITING

CHU Nantes

Nantes, 44000, France

RECRUITING

Clinique Jules Verne

Nantes, 44300, France

RECRUITING

Centre Hospitalier Régional et Universitaire d'Orléans

Orléans, France

RECRUITING

Hopital Pontchaillou

Rennes, 35000, France

RECRUITING

Clinique Mutualiste de la Sagesse

Rennes, France

NOT YET RECRUITING

Clinique Santé Atlantique

Saint-Herblain, 44800, France

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emeric Abet, Dr

  CHD Vendée

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnès Dorion

CONTACT

251446380; agnes.dorion@chd-vendee.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: December 7, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)