Observational Recruiting
NCT04930029 on ClinicalTrials.gov
Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
- Sponsor: Hôpital Roger Salengro
- Enrollment: 320 (Estimated)
- Study start: 2021-09-15 (Actual)
- Primary completion: 2026-07-01 (Estimated)
- Study completion: 2026-07-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief Summary
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
- Bypass Complication
- Obesity
Intervention / Treatment
- Other: Ten year evaluation
Primary Outcome Measures
-
Incidence of serious surgery-related adverse events
(10 years after surgery)
A serious adverse event is defined as a medical event that requires hospitalization, is life-threatening, results in persistent or substantial disability, or results in death. The "surgery-related" character will be described by each investigator in the first instance and homogenized by the group of experts designated at the beginning of the study.
Countries
France
Locations and Investigators
- Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne, Lille, France (Recruiting)
Study Officials
- Robert CAIAZZO, MD,PhD (Principal Investigator) — University Hospital, Lille