Long-term adverse effects of omega (one-anastomosis) gastric bypass
Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
We'll see if people who had an omega (one‑anastomosis) gastric bypass with a 150‑cm versus 200‑cm biliary limb have different rates of serious surgery‑related problems about 10 years after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04930029 on ClinicalTrials.gov |
What this trial studies
This observational project compares patients who received an omega (one‑anastomosis) gastric bypass with either a 150‑cm or 200‑cm biliary limb, focusing on outcomes roughly 10 years after surgery. Consecutive eligible patients operated between 2009 and 2013 will be invited for clinical follow‑up including endoscopy with biopsies, nutritional laboratory tests, weight and comorbidity assessments, and quality‑of‑life measures. The primary outcome is the incidence of serious adverse events related to surgery at 10 years, with secondary outcomes addressing protein and other nutritional deficiencies, gastroesophageal findings, weight trajectory, and resolution of comorbidities. Data are collected observationally at Hôpital Claude Huriez (University Hospital, Lille) using medical records and prospective 10‑year evaluations.
Who should consider this trial
Good fit: People who had an OAGB with a 150‑cm or 200‑cm biliary limb between 2009 and 2013 (about 10 ± 2 years ago), who can consent, undergo endoscopy with biopsies, and have health insurance are ideal candidates.
Not a fit: Patients who had a different bariatric procedure, are outside the ~8–12 year post‑op window, cannot undergo endoscopy, are under guardianship or deprived of liberty, or are enrolled in conflicting protocols are unlikely to benefit from participation.
Why it matters
Potential benefit: If one limb length shows fewer long‑term surgical or nutritional complications, the results could help surgeons choose the safer OAGB configuration and reduce late complications.
How similar studies have performed: Case reports and small series have reported nutritional deficiencies and reflux after OAGB, but long‑term comparative data by biliary limb length are limited, so this specific 150‑cm versus 200‑cm comparison remains incompletely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who received 10 ± 2 years ago (between 2009 and 2013) an OAGB with a 150 or 200cm biliary limb. Patients should be consecutive at each center. * Patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the HAS (HAS, 2009) in an expert center. * Patients agreeing to perform an endoscopic evaluation with biopsies at 10 years * Patients who gave their consent * Patients with health insurance coverage Exclusion Criteria: * Contraindication to bariatric surgery defined according to HAS recommendations (HAS, 2009) * Persons deprived of liberty, under guardianship, or under curatorship * Patients included in a protocol with a conflict of interest with OMEGA10.
Where this trial is running
Lille
- Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne — Lille, France (Recruiting)
Study contacts
- Principal investigator: Robert CAIAZZO, MD,PhD — University Hospital, Lille
- Study coordinator: Robert CAIAZZO, MD,PhD
- Email: robert.caiazzo@chru-lille.fr
- Phone: 0320445962
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.