A study on safety and efficacy comparing 150cm One Anastomosis Gastric Bypass with 150cm BP limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An open label, multicentre non-inferiority randomized controlled trial
Recruiting
- Conditions
- obesitasObestityoverweight1001842410017998
- Registration Number
- NL-OMON54369
- Lead Sponsor
- Flevoziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 298
Inclusion Criteria
Inclusion criteria are BMI >40kg/m2, or BMI >35kg/m2 with at least one of the
following comorbidities: type 2 diabetes, hypertension, dyslipidaemia,
obstructive sleep apnoea, or osteoarthritis of the hip or knee; age 18-65
years; positive evaluation by a Bariatric multidisciplinary team (BMDT,
consisting of psychologists, dietitians, internists and bariatric surgeons);
and written informed consent
Exclusion Criteria
Exclusion criteria will be presence of Helicobacter pylori resistant to
eradication therapy, the presence of chronic diarrhoea, or previous bariatric
or extensive abdominal surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>% excess BMI loss at 2 years</p><br>
- Secondary Outcome Measures
Name Time Method