NCT04852198

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (estimated)
• Sponsor: Flevoziekenhuis · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Bariatric Surgery Candidate
• Obesity
• Obesity, Morbid

Interventions

Type	Name	Description
PROCEDURE	OAGB	Simplified gastric bypass procedure
PROCEDURE	RYGB	Roux-en-Y gastric bypass. Standard procedure in the Netherlands

Timeline

• Start date: 2021-12-13
• Primary completion: 2027-06-13
• Completion: 2029-11-01
• First posted: 2021-04-21
• Last updated: 2024-04-23

Locations

2 sites across 1 country: Netherlands