Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
Recruiting · NCT04930029 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
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 is running
1 location listed.
- Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne - Lille, France