Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Obesity Clinical Trial

— Sleevepexie  

Official title:

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994665
• Other study ID #: CHD21-0032
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Obesity

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