Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Launched by CENTRE HOSPITALIER DEPARTEMENTAL VENDEE · Jul 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a surgical technique called omentopexy on a condition known as gastro-oesophageal reflux disease (GERD) in patients who have undergone sleeve gastrectomy for obesity. Essentially, the researchers want to find out if adding omentopexy, a procedure that involves repositioning a part of the stomach lining, can help reduce the chances of developing GERD two years after surgery, without the need for medication like Proton-Pump Inhibitors (PPIs).

To participate in this study, individuals must be at least 18 years old and have a body mass index (BMI) between 35 and 40, along with at least one obesity-related health issue, or a BMI of 40 or higher. Participants will be randomly assigned to one of two groups: one will have just the sleeve gastrectomy, while the other will have both the sleeve gastrectomy and the omentopexy. After two years, their quality of life and reflux symptoms will be evaluated using specific scoring systems. This trial is currently recruiting participants and aims to provide important insights into improving patient outcomes after weight loss surgery.

Gender

ALL

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 at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.
• • 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