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

Study Overview
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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).

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

Conditions
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Bypass Complication, Obesity

Intervention / Treatment
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* Other: Ten year evaluation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OAGB150<br>One anastomosis gastric bypass with 150cm biliary limb | Other: Ten year evaluation<br>* Clinical, biological and endoscopic evaluation<br>|
| OAGB200<br>One anastomosis gastric bypass with 200cm biliary limb | Other: Ten year evaluation<br>* Clinical, biological and endoscopic evaluation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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One anastomosis gastric bypass, obesity, bariatric surgery, GERD, long term