Status:
UNKNOWN
Roux-en-Y Gastric Bypass (RYGB) Versus Omega-Loop Gastric Bypass (OLGB) Safety and Efficacy Short-term Study
Lead Sponsor:
Nemocnice Břeclav, p.o.
Conditions:
Obesity, Severe
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The aim of this study is to compare the relative clinical outcomes between two variants of gastric bypass \[Roux-en-Y Gastric Bypass (RYGB) or Omega-Loop Gastric Bypass (OLGB)\] in metabolic surgery c...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02290418
Start Date
January 1 2012
End Date
December 1 2018
Last Update
November 14 2014
Active Locations (1)
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1
Bariatric Clinic, Breclav Hospital
Břeclav, Czechia, 690 74