Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
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)
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