Gastric Bypass Clinical Trials

Clinical trials related to Gastric Bypass Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne
RECRUITING
Lille
Contact Information
Primary
Robert CAIAZZO, MD,PhD
robert.caiazzo@chru-lille.fr
0320445962
Time Frame
Start Date: 2021-09-15
Estimated Completion Date: 2026-07
Participants
Target number of participants: 320
Treatments
OAGB150
One anastomosis gastric bypass with 150cm biliary limb
OAGB200
One anastomosis gastric bypass with 200cm biliary limb
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov