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

Obesity Clinical Trial

— Roux-en-WHY?  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852198
• Other study ID #: FZ 20/22
• Secondary ID: NL74137.018.20
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: November 1, 2029

Study information

• Verified date: April 2024
• Source: Flevoziekenhuis
• Contact: Stef JM Smeets, MD PhD
• Phone: 0031368688888
• Email: ssmeets[@]flevoziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 298
• Est. completion date: November 1, 2029
• Est. primary completion date: June 13, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• OAGB
Simplified gastric bypass procedure
• RYGB
Roux-en-Y gastric bypass. Standard procedure in the Netherlands

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	OLVG	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Flevoziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

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