Clinical trial

Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega

Recruiting now · Not applicable · 1 countries · Registry ID NCT04930029

Recruiting nowNot applicableObservational

What this study 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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionBypass Complication, Obesity

Full registry 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.

Treatments and study arms

Ten year evaluation

Other

Clinical, biological and endoscopic evaluation

Primary outcomes

Incidence of serious surgery-related adverse events10 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne🇫🇷 Lille, France

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Robert CaiazzoContact

Email · Call 03 20 44 42 73