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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04852198

Acronym

Roux-en-WHY?

Enrollment

298

Registered

2021-04-21

Start date

2021-12-13

Completion date

2029-11-01

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Obesity, Obesity, Morbid

Brief summary

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

PROCEDUREOAGB

Simplified gastric bypass procedure

PROCEDURERYGB

Roux-en-Y gastric bypass. Standard procedure in the Netherlands

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized controlled trial with 2 groups

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Netherlands

Contacts

Primary ContactStef JM Smeets, MD PhD

ssmeets@flevoziekenhuis.nl0031368688888

Backup ContactFloris Bruinsma, Student

fbruinsma@flevoziekenhuis.nl0031368688888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026