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Recruiting NCT04930029

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

— Observational Bypass Complication Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ten year evaluation.
Who it may be relevant to
Registry conditions: Bypass Complication, Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • Other Ten year evaluation
    Clinical, biological and endoscopic evaluation

Primary outcome measures

  • Incidence of serious surgery-related adverse events [Time frame: 10 years after surgery]
Secondary outcome measures (12)
  • incidence of serious adverse events not related to surgery [Time frame: 10 years after surgery]
  • Nutritional biological status , assessed by evaluation of malnutrition parameters [Time frame: 10 years after surgery]
  • Nutritional clinical status, assessed by dietitian evaluation [Time frame: 10 years after surgery]
  • Excess weight loss percentage [Time frame: 10 years after surgery]
  • Metabolic comorbidities remission [Time frame: 10 years after surgery]
  • Diabetes remission [Time frame: 10 years after surgery]
  • Hypertension remission [Time frame: 10 years after surgery]
  • Obstructive sleep apnea remission [Time frame: 10 years after surgery]
  • Dyslipidemia remission [Time frame: 10 years after surgery]
  • Quality of life by BAROS score (Bariatric analysis and reporting outcome system) [Time frame: 10 years after surgery]
  • Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires [Time frame: 10 years after surgery]
  • GERD [Time frame: 10 years after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne — Lille

Identifiers

NCT: NCT04930029 · 2020_82 · 2020-A03156-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗