Actively Recruiting
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
Led by Flevoziekenhuis · Updated on 2024-04-23
298
Participants Needed
2
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two types of gastric bypass surgeries for patients with obesity or morbid obesity. The study compares One Anastomosis Gastric Bypass (OAGB) with Roux-en-Y Gastric Bypass (RYGB) to determine which procedure provides better weight loss and metabolic control while minimizing side effects and complications. This multicenter, open-label, randomized controlled trial aims to find the optimal surgical approach for eligible patients aged 18 to 65 with specific body mass index (BMI) and comorbidities. Participants will be randomly assigned to one of two groups: one receiving the OAGB procedure with a 150cm biliopancreatic limb, and the other undergoing the RYGB procedure with a 150cm biliopancreatic limb and a 75cm alimentary limb. Both procedures are established gastric bypass surgeries performed to help with weight loss and metabolic improvement. The study's main focus is to measure excess BMI loss two years after surgery. During the study, participants will be monitored for their weight loss progress, metabolic health, nutritional status, remission of comorbid conditions, quality of life, and any complications or serious adverse events. Researchers will collect data over a two-year period following surgery to assess these outcomes. The trial is sponsored by Flevoziekenhuis and is designed to provide insights into the relative benefits and risks of these two surgical options for patients needing bariatric surgery.
CONDITIONS
Brief Title
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body-mass index (BMI) of 40 kg/m2 or higher, or 35 kg/m2 or higher with at least one comorbidity such as type 2 diabetes, high blood pressure, obstructive sleep apnea, dyslipidaemia, or osteoarthritis of the hip or knee
- Positive evaluation by the bariatric multidisciplinary team (BMDT)
- Age between 18 and 65 years
You will not qualify if you...
- Presence of Helicobacter pylori infection resistant to eradication therapy
- Chronic diarrhea
- History of previous bariatric or extensive abdominal surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo one of two types of gastric bypass surgery followed by immediate post-operative care.
1 surgery visit and multiple immediate post-operative visits
Duration - Up to 2 years
Participants attend follow-up visits to monitor weight loss, metabolic control, nutritional status, comorbidities, quality of life, and any complications or adverse events.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 2 locations
1
Flevoziekenhuis
Almere Stad, Netherlands, 1315RA
Actively Recruiting
2
OLVG
Amsterdam, Netherlands, 1061AE
Not Yet Recruiting
Research Team
S
Stef JM Smeets, MD PhD
F
Floris Bruinsma, Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here