Roux-en-Y Gastric Bypass (RYGB) Versus Omega-Loop Gastric Bypass (OLGB) Safety and Efficacy Short-term Study
Launched by NEMOCNICE BŘECLAV, P.O. · Nov 10, 2014
Trial Information
Current as of August 27, 2025
Unknown status
Keywords
ClinConnect Summary
Introduction:
Obesity is a risk factor for Diabetes, Ischemic heart disease, Stroke, and Hypertensive heart disease, which are the 6th, 1st, 2nd, and 10th leading causes of death according to the WHO. Bariatric or Metabolic Surgery is an Efficient and reasonably Safe method for the Treatment of Severe Obesity, Type 2 Diabetes (T2DM) and Metabolic Syndrome (MS).
Existing knowledge:
Metabolic procedures, e.g. Gastric bypass, are more effective in the treatment of T2DM than predominantly "restrictive" procedures, e.g. Gastric Banding. RYGB is one of the most prevalent procedures in the worl...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Severe Obesity: BMI ≥ 40 and ≤ 50 or (BMI ≥ 35 and \< 40 and type 2 diabetes or metabolic syndrome)
- • Inadequate results of Attempts to loose weight by Conservative means
- • Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups
- • no contraindication for bariatric surgery on psychological assessment
- • no contraindication for general anesthesia
- • consent for both variants of gastric bypass surgery
- • consent to participate in a study with randomized design
- Exclusion Criteria:
- • prior bariatric surgery of any kind
- • gravidity or recent (\<1 year) labour
- • drug or alcohol abuse
- • symptomatic Gastro Esophageal Reflux Disease (GERD)
- • hiatal hernia, \> 3cm
- • esophagitis, ≥ 2. grade
- • active smoker
- • chronic renal disease, stage ≥ 3
- • patient immobility
- • surgery not covered by universal insurance in Czech rep. (i.e. international patients)
About Nemocnice Břeclav, P.O.
Nemocnice Břeclav, p.o. is a leading healthcare institution located in Břeclav, Czech Republic, dedicated to providing high-quality medical services and advancing clinical research. As a recognized clinical trial sponsor, the hospital is committed to enhancing patient care through innovative research initiatives and collaborations. With a focus on ethical practices and patient safety, Nemocnice Břeclav actively participates in a range of clinical trials aimed at developing new treatments and therapies across various medical disciplines. The institution is equipped with modern facilities and a multidisciplinary team of healthcare professionals, ensuring rigorous adherence to clinical trial protocols and regulatory standards.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Breclav, , Czech Republic
Patients applied
Trial Officials
Michal Cierny, Dr.
Study Director
Breclav Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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