Actively Recruiting
Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
Led by University Hospital, Lille · Updated on 2025-12-26
320
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. In its technology assessment report issued in September 2019 (HAS, 2019), the Haute Autorité de Santé rules on the invalidity of OAGB with a 200 cm biliary limb and the lack of sufficient data on the safety of OAGB with a 150 cm biliary limb compared to RYGB. The lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted. The main objective of the study is to compare the incidence of serious adverse events related to surgery after OAGB at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (OAGB AB150) versus a realization with a 200-cm biliary loop (OAGB AB200).
CONDITIONS
Official Title
Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who received an omega gastric bypass with a 150 or 200 cm biliary limb between 2009 and 2013
- Patients who met criteria for bariatric surgery at the time of their operation according to expert center recommendations
- Patients willing to undergo an endoscopic evaluation with biopsies at 10 years
- Patients who have given their consent
- Patients with health insurance coverage
You will not qualify if you...
- Contraindications to bariatric surgery as defined by expert recommendations
- Individuals deprived of liberty, under guardianship, or under curatorship
- Patients involved in a conflicting protocol with OMEGA10
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne
Lille, France
Actively Recruiting
Research Team
R
Robert CAIAZZO, MD,PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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