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

NCT04930029 | Recruiting

• 2 other identifiers: 2020_822020-A03156-33
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bypass Complication; Obesity

Keywords

One anastomosis gastric bypass; obesity; bariatric surgery; GERD; long term

Outcome Measures

Primary Outcomes (1)

• Incidence of serious surgery-related adverse events

  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.

  10 years after surgery

Secondary Outcomes (12)

• incidence of serious adverse events not related to surgery

  10 years after surgery

• Nutritional biological status , assessed by evaluation of malnutrition parameters

  10 years after surgery

• Nutritional clinical status, assessed by dietitian evaluation

  10 years after surgery

• Excess weight loss percentage

  10 years after surgery

• Metabolic comorbidities remission

  10 years after surgery

Study Arms (2)

OAGB150

One anastomosis gastric bypass with 150cm biliary limb

Other: Ten year evaluation

OAGB200

One anastomosis gastric bypass with 200cm biliary limb

Other: Ten year evaluation

Interventions

Ten year evaluation OTHER

Clinical, biological and endoscopic evaluation

OAGB150; OAGB200

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study involves patients: * operated between 2008 and 2013 for an OAGB with a 150 or 200cm biliary limb * fulfilling the HAS criteria(HAS, 2009) at the time of their surgery: BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with a comorbidity likely to be improved by weight loss * benefiting from a follow-up.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne

Lille, France

RECRUITING

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robert CAIAZZO, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert CAIAZZO, MD,PhD

CONTACT

0320445962; robert.caiazzo@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: September 15, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)