Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial (Roux-en-WHY?)

April 18, 2024 updated by: Flevoziekenhuis

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OAGB
149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm
Procedure: OAGB
Simplified gastric bypass procedure
Other Names:
  • Mini gastric bypass
  • Omega loop gastric bypass
Active Comparator: RYGB
149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm
Procedure: RYGB
Roux-en-Y gastric bypass. Standard procedure in the Netherlands

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flevoziekenhuis

Investigators

  • Principal Investigator: Stef JM Smeets, MD PhD, Flevoziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Estimated)

June 13, 2027

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZ2022
  • NL74137.018.20 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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