Status:
UNKNOWN
Long or Very Long-Limb Gastric Bypass in Superobese
Lead Sponsor:
Kaunas University of Medicine
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI\>50) pat...
Detailed Description
The study is a multicentre trial in which superobese (BMI\>50) patients will be randomly assigned (in a 1:1 ratio) for laparoscopic gastric Roux-en-Y gastric bypass with: a) long (150 cm) or b) very l...
Eligibility Criteria
Inclusion
- Hospitalized male or female subjects 18-65 years of age.
- Obese subjects with body mass index (BMI= kg/m²)\>50
- Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition.
- Patients who read the informed consent form and gave a written consent to participate in the study.
Exclusion
- Previous open abdominal surgery, except appendectomy, cholecystectomy and gynaecological procedures.
- Presence of any significance cardiac, hepatic, renal, blood, alimentary tract disease which may lead to system or organ failure in intraoperative or postoperative period.
- Pregnant women.
- Subjects taking immunosuppressive therapy.
- Any concomitant condition that, in the opinion of the investigator, would preclude an operation and postoperative follow up acording to a protocol
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00868543
Start Date
July 1 2008
End Date
December 1 2015
Last Update
March 25 2009
Active Locations (1)
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1
KMUK, surgery department
Kaunas, Lithuania, 50009