Overview
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
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)
Eligibility
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