Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
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: OAGB, RYGB.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Obesity, Obesity, Morbid. Basic parameters: 18 years — 65 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
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Detailed description
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)
Interventions
- Procedure OAGB
Simplified gastric bypass procedure - Procedure RYGB
Roux-en-Y gastric bypass. Standard procedure in the Netherlands
Primary outcome measures
- Percentage excess BMI loss at 2 years (%EBMIL) [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Flevoziekenhuis — Almere Stad
- OLVG — Amsterdam
Identifiers
NCT: NCT04852198 · FZ 20/22 · NL74137.018.20