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

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ClinicalTrials.gov Identifier: NCT04994665
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Study Description
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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)


Condition or disease Intervention/treatment Phase
Obesity Procedure: sleeve gastrectomy Procedure: sleeve gastrectomy with omentopexy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : November 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sleeve gastrectomy
realization of a sleeve gastrectomy alone
 Procedure: sleeve gastrectomy
The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
Experimental: sleeve gastrectomy with omentopexy
realization of a sleeve gastrectomy followed by an omentopexy
 Procedure: sleeve gastrectomy with omentopexy
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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04994665


Contacts
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Contact: Agnès Dorion 251446380 ext +33 agnes.dorion@chd-vendee.fr

Locations
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France
CHD Vendée Recruiting
La Roche sur Yon, France, 85000
Principal Investigator: Emeric ABET, Dr         
Centre Hospitalier Emile Roux Not yet recruiting
Le Puy-en-Velay, France, 43012
Principal Investigator: Luis Matias BRUNA         
CHU Nantes Recruiting
Nantes, France, 44000
Principal Investigator: Claire BLANCHARD, Dr         
Clinique Jules Verne Not yet recruiting
Nantes, France, 44300
Principal Investigator: Laurent POTIRON         
Hopital Pontchaillou Recruiting
Rennes, France, 35000
Principal Investigator: Damien BERGEAT, Dr         
Clinique Santé Atlantique Recruiting
Saint-Herblain, France, 44800
Principal Investigator: Antoine SINA, Dr         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Emeric Abet, Dr CHD Vendée
More Information
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT04994665    
Other Study ID Numbers: CHD21-0032
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Departemental Vendee:
sleeve gastrectomy
omentopexy
gastro-oesophageal disease
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases