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

Not Applicable

Recruiting

• Conditions: Obesity; Bariatric Surgery Candidate; Obesity, Morbid
• Interventions: Procedure: OAGB; Procedure: RYGB

• Registration Number: NCT04852198
• Lead Sponsor: Flevoziekenhuis

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)

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Study Start: 2021-12-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2027-06-13
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OAGB	OAGB	149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm
RYGB	RYGB	149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm

Primary Outcome Measures

Name	Time	Method
Percentage excess BMI loss at 2 years (%EBMIL)	2 years	Percentage excess BMI loss after 2 years of follow-up

Trial Locations

Locations (2)

OLVG; 🇳🇱 Amsterdam, Netherlands

Flevoziekenhuis; 🇳🇱 Almere, Netherlands