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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04994665
Other study ID # CHD21-0032
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 7, 2021
Est. completion date November 1, 2028

Study information

Verified date June 2024
Source Centre Hospitalier Departemental Vendee
Contact Agnès Dorion
Phone 251446380
Email agnes.dorion@chd-vendee.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 526
Est. completion date November 1, 2028
Est. primary completion date November 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CH de la Cote Basque Bayonne
France CHD Vendée La Roche sur Yon
France Centre Hospitalier Emile Roux Le Puy-en-Velay
France CHU Nantes Nantes
France Clinique Jules Verne Nantes
France Centre Hospitalier Régional et Universitaire d'Orléans Orléans
France Clinique Mutualiste de la Sagesse Rennes
France Hopital Pontchaillou Rennes
France Clinique Santé Atlantique Saint-Herblain

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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