Long-term safety of omega gastric bypass surgery in adults with obesity
Compares serious complications after omega gastric bypass with 150 cm or 200 cm loops.
Key facts
- Who runs it
- University Hospital, Lille
- Where
- Lille, FranceSee the site
- Trial code
- Registry title
- Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
- Status
- Recruiting
- People taking part
- 320 people, planned
- Started
- 15 Sept 2021
- Planned end
- Jul 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Ten year evaluation
- Record updated
- 26 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had one-anastomosis (omega) gastric bypass surgery about 10 years ago, with a 150 cm (4 ft 11 in) or 200 cm (6 ft 7 in) biliary limb.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Patients who met the criteria for weight-loss (bariatric) surgery at the time of their operation, according to the HAS recommendations, in an expert center.
- Earlier treatment
- Must have had omega gastric bypass (OAGB) 10 ± 2 years ago, between 2009 and 2013, with a 150 or 200 cm (4 ft 11 in–6 ft 7 in) biliary limb.
Main reasons for not taking part
- A contraindication to weight-loss surgery, as defined by the HAS recommendations
- People deprived of liberty, under guardianship or under curatorship
- Patients in another study that conflicts with OMEGA10
- People who do not agree to an endoscopy with biopsies at 10 years
- People without health insurance coverage
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in France
- Hôpital Claude Huriez - Service de chirurgie générale et endocrinienneLille, FranceContact: Robert CaiazzoTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
The 2 groups in the trial
- OAGB150
One anastomosis gastric bypass with 150cm biliary limb
Treatment: Ten year evaluation
- OAGB200
One anastomosis gastric bypass with 200cm biliary limb
Treatment: Ten year evaluation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
- Plain-language title
- Long-term safety of omega gastric bypass surgery in adults with obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 26 December 2025