Comparing two types of gastric bypass surgeries for weight loss
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
This study is testing whether One Anastomosis Gastric Bypass can help people with obesity lose weight and improve their health just as well as the more common Roux-en-Y Gastric Bypass.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 298 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Flevoziekenhuis Academic / other |
| Locations | 2 sites (Almere Stad and 1 other locations) |
| Trial ID | NCT04852198 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of One Anastomosis Gastric Bypass (OAGB) compared to Roux-en-Y Gastric Bypass (RYGB) in patients with obesity. It is a multicenter, open-label, non-inferiority randomized controlled trial that will assess surgical outcomes, including weight loss and metabolic control, over a two-year period. The study will include patients with a body mass index (BMI) of 40 or higher, or 35 or higher with comorbidities, who have been positively evaluated by a bariatric multidisciplinary team. The primary endpoint is the percentage of excess BMI loss at two years, with secondary endpoints focusing on metabolic status, nutritional status, comorbidity remission, quality of life, and complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a BMI of 40 or higher, or 35 or higher with at least one obesity-related comorbidity.
Not a fit: Patients with a history of previous bariatric surgery or extensive abdominal surgery, or those with chronic diarrhea or resistant H. Pylori infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which surgical procedure offers better outcomes for weight loss and metabolic health with fewer complications.
How similar studies have performed: Other studies comparing gastric bypass techniques have shown promising results, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Almere Stad and 1 other locations
- Flevoziekenhuis — Almere Stad, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Stef JM Smeets, MD PhD — Flevoziekenhuis
- Study coordinator: Stef JM Smeets, MD PhD
- Email: ssmeets@flevoziekenhuis.nl
- Phone: 0031368688888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.