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

NCT ID: NCT04930029

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2026-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Bypass Complication Obesity

Keywords

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One anastomosis gastric bypass obesity bariatric surgery GERD long term

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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OAGB150

One anastomosis gastric bypass with 150cm biliary limb

Ten year evaluation

Intervention Type OTHER

Clinical, biological and endoscopic evaluation

OAGB200

One anastomosis gastric bypass with 200cm biliary limb

Ten year evaluation

Intervention Type OTHER

Clinical, biological and endoscopic evaluation

Interventions

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Ten year evaluation

Clinical, biological and endoscopic evaluation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert CAIAZZO, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Robert CAIAZZO, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Robert Caiazzo

Role: primary

Other Identifiers

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2020_82

Identifier Type: -

Identifier Source: org_study_id

2020-A03156-33

Identifier Type: OTHER

Identifier Source: secondary_id