Evaluating the effect of omentopexy on reflux after sleeve gastrectomy
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
This study is testing if adding a procedure called omentopexy during sleeve gastrectomy can help prevent new cases of acid reflux in patients after their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 526 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 9 sites (Bayonne and 8 other locations) |
| Trial ID | NCT04994665 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of omentopexy on the development of gastro-oesophageal reflux disease (GERD) following sleeve gastrectomy. It is a prospective, multicentric, randomized trial involving 526 patients, divided into two groups: one undergoing sleeve gastrectomy alone and the other undergoing sleeve gastrectomy with omentopexy. The evaluation will occur two years post-surgery, utilizing the CARLSSON and BAROS scores to measure quality of life and reflux rates. The primary goal is to demonstrate that omentopexy reduces the incidence of de novo GERD without relying on Proton-Pump Inhibitors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with obesity-related comorbidities and a BMI between 35 and 40 kg/m² or a BMI of 40 kg/m² or higher.
Not a fit: Patients with eating disorders, mental disorders, or those with a BMI below 35 kg/m² are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of GERD in patients undergoing sleeve gastrectomy, improving their quality of life.
How similar studies have performed: While the specific approach of omentopexy in this context may be novel, similar studies have shown promising results in managing GERD post-bariatric surgery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bayonne and 8 other locations
- CH de la Cote Basque — Bayonne, France (Recruiting)
- CHD Vendée — La Roche-sur-Yon, France (Recruiting)
- Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- Clinique Jules Verne — Nantes, France (Recruiting)
- Centre Hospitalier Régional et Universitaire d'Orléans — Orléans, France (Recruiting)
- Hopital Pontchaillou — Rennes, France (Recruiting)
- Clinique Mutualiste de la Sagesse — Rennes, France (Not_yet_recruiting)
- Clinique Santé Atlantique — Saint-Herblain, France (Recruiting)
Study contacts
- Principal investigator: Emeric Abet, Dr — CHD Vendée
- Study coordinator: Agnès Dorion
- Email: agnes.dorion@chd-vendee.fr
- Phone: 251446380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.