search
Back to results

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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sleeve gastrectomy
sleeve gastrectomy with omentopexy
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring sleeve gastrectomy, omentopexy, gastro-oesophageal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHD VendéeRecruiting
  • Centre Hospitalier Emile Roux
  • CHU NantesRecruiting
  • Clinique Jules Verne
  • Hopital PontchaillouRecruiting
  • Clinique Santé AtlantiqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sleeve gastrectomy

sleeve gastrectomy with omentopexy

Arm Description

realization of a sleeve gastrectomy alone

realization of a sleeve gastrectomy followed by an omentopexy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 29, 2021
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Departemental Vendee
search

1. Study Identification

Unique Protocol Identification Number
NCT04994665
Brief Title
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Acronym
Sleevepexie
Official Title
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
sleeve gastrectomy, omentopexy, gastro-oesophageal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
526 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
realization of a sleeve gastrectomy alone
Arm Title
sleeve gastrectomy with omentopexy
Arm Type
Experimental
Arm Description
realization of a sleeve gastrectomy followed by an omentopexy
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Intervention Description
The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy with omentopexy
Intervention Description
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 Outcome Measure Information:
Title
Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
Description
Presence of de novo GERD defined by a clinical score of CARLSSON >= 4 and/or the use of a PPIs treatment
Time Frame
2 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès Dorion
Phone
251446380
Ext
+33
Email
agnes.dorion@chd-vendee.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emeric Abet, Dr
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHD Vendée
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emeric ABET, Dr
Facility Name
Centre Hospitalier Emile Roux
City
Le Puy-en-Velay
ZIP/Postal Code
43012
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Matias BRUNA
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BLANCHARD, Dr
Facility Name
Clinique Jules Verne
City
Nantes
ZIP/Postal Code
44300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent POTIRON
Facility Name
Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien BERGEAT, Dr
Facility Name
Clinique Santé Atlantique
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine SINA, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

We'll reach out to this number within 24 hrs