Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega (OMEGA10)

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Bypass Complication
• Intervention / Treatment: Other: Ten year evaluation

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Robert CAIAZZO, MD,PhD; Phone Number: +33 0320445962; Email: robert.caiazzo@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne
    • Contact: Robert Caiazzo; Phone Number: 03 20 44 42 73; Email: robert.caiazzo@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OAGB150; One anastomosis gastric bypass with 150cm biliary limb	Other: Ten year evaluation; Clinical, biological and endoscopic evaluation
OAGB200; One anastomosis gastric bypass with 200cm biliary limb	Other: Ten year evaluation; Clinical, biological and endoscopic evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	calculated as follows: (weight at 10 years - initial weight) / (initial weight - ideal weight) x 100 The ideal weight is defined as the weight corresponding to a BMI = 25 kg/m2. The initial weight is the weight on the day of surgery.	10 years after surgery
Metabolic comorbidities remission		10 years after surgery
Diabetes remission		10 years after surgery
Hypertension remission		10 years after surgery
Obstructive sleep apnea remission		10 years after surgery
Dyslipidemia remission		10 years after surgery
Quality of life by BAROS score (Bariatric analysis and reporting outcome system)		10 years after surgery
Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires	The GIQLI is a score to evaluate digestive disorders in 36 items, ranging from 0 (the worst quality of life) to 144 (the best quality of life).	10 years after surgery
GERD	GERD, assessed by clinical evaluation, PPI use, and endoscopic signs of GERD (gastritis, oesophagitis, anastomotic ulcer, Barrett's esophagus, gastric metaplasia, esophageal metaplasia	10 years after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Robert Caiazzo, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: GERD; obesity; bariatric surgery; long term; One anastomosis gastric bypass
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Overweight; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Gastroesophageal Reflux
• Other Study ID Numbers: 2020_82; 2020-A03156-33 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No