Clinical trial NCT04994665: Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Official title: Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: sleeve gastrectomy
omentopexy
gastro-oesophageal disease
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
timeFrame: 2 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH de la Cote Basque
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Nantes
country: France
facility: CHU Nantes
city: Nantes
country: France
facility: Clinique Jules Verne
city: Orléans
country: France
facility: Centre Hospitalier Régional et Universitaire d'Orléans
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Rennes
country: France
facility: Clinique Mutualiste de la Sagesse
city: Saint-Herblain
country: France
facility: Clinique Santé Atlantique
Study officials:
affiliation: CHD Vendée
name: Emeric Abet, Dr
role: PRINCIPAL_INVESTIGATOR
References: