Long-term adverse effects of omega (one-anastomosis) gastric bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.