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NCT Number: NCT04930029

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

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).

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Key information

Conditions

Bypass Complication Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne

Lille, France

Location status: Recruiting

Location contact

Robert Caiazzo

CONTACT

[email protected]

03 20 44 42 73

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ten year evaluation

Other

Clinical, biological and endoscopic evaluation

Primary outcomes

  1. Incidence of serious surgery-related adverse events

    Time frame: 10 years after surgery

    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.

Secondary outcomes

  1. incidence of serious adverse events not related to surgery

    Time frame: 10 years after surgery

  2. Nutritional biological status , assessed by evaluation of malnutrition parameters

    Time frame: 10 years after surgery

  3. Nutritional clinical status, assessed by dietitian evaluation

    Time frame: 10 years after surgery

  4. Excess weight loss percentage

    Time frame: 10 years after surgery

    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.

  5. Metabolic comorbidities remission

    Time frame: 10 years after surgery

  6. Diabetes remission

    Time frame: 10 years after surgery

  7. Hypertension remission

    Time frame: 10 years after surgery

  8. Obstructive sleep apnea remission

    Time frame: 10 years after surgery

  9. Dyslipidemia remission

    Time frame: 10 years after surgery

  10. Quality of life by BAROS score (Bariatric analysis and reporting outcome system)

    Time frame: 10 years after surgery

  11. Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires

    Time frame: 10 years after surgery

    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).

  12. GERD

    Time frame: 10 years after surgery

    GERD, assessed by clinical evaluation, PPI use, and endoscopic signs of GERD (gastritis, oesophagitis, anastomotic ulcer, Barrett's esophagus, gastric metaplasia, esophageal metaplasia

Study contacts

Contact information is provided by the study sponsor or research team.

Robert CAIAZZO, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: OMEGA10

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2021
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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