Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB

Detailed Description
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Rationale: to compare two different types of gastric bypass operations on surgical outcome. Objective: to compare two established procedures in order to find the optimal procedure in terms of weight loss and metabolic control that is associated with the fewest side-effects and complications, and decreased invasiveness. Study design: A multicentre, open label, non-inferiority randomized controlled trial Study population: Patients are eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) and a positive evaluation by our bariatric multidisciplinary team (BMDT) and are aged 18-65. Intervention: Group 1: One Anastomosis Gastric Bypass with 150cm biliopancreatic limb. Group 2: Roux-en-Y gastric bypass with biliopancreatic limb of 150cm and 75cm alimentary limb. Main study parameters/endpoints: Primary endpoint: % Excess BMI loss at two years Secondary endpoints: Metabolic status Nutritional status Comorbidity remission QOL Complications or serious adverse events (SAE's)

Official Title
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A Study on Safety and Efficacy Comparing 150cm One Anastomosis Gastric Bypass With 150cm Biliopancreatic Limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An Open Label, Multicentre Non-inferiority Randomized Controlled Trial

Conditions
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Bariatric Surgery Candidate, Obesity, Obesity, Morbid

Intervention / Treatment
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* Procedure: OAGB
* Procedure: RYGB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body-mass index (BMI) of 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) a positive evaluation by our BMDT Exclusion Criteria: Presence of H. Pylori, resistant to eradication therapy chronic diarrhoea history of previous bariatric or extensive abdominal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with 2 groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OAGB<br>149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm | Procedure: OAGB<br>* Simplified gastric bypass procedure<br>* Other names: Omega loop gastric bypass;|
| Active Comparator: RYGB<br>149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm | Procedure: RYGB<br>* Roux-en-Y gastric bypass. Standard procedure in the Netherlands<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage excess BMI loss at 2 years (%EBMIL) | Percentage excess BMI loss after 2 years of follow-up | 2 years |