Status:
RECRUITING
A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastrectomy
Lead Sponsor:
Methodist Health System
Collaborating Sponsors:
Intuitive Surgical
Conditions:
Laparoscopic Sleeve Gastrectomy
Sleeve Gastrectomy
Eligibility:
All Genders
18+ years
Brief Summary
The prevalence of obesity has tripled in the last 50 years with presently about 1.7 billion of the world population aged 18 years and over either overweight or obese.1 In the US alone, 35% of the popu...
Detailed Description
Procedure Description 1.2.1 Roux-en-Y Gastric Bypass The RYGB connects a limb of the intestine to a much smaller stomach pouch, which prevents the bile from entering the upper part of the stomach and ...
Eligibility Criteria
Inclusion
- Subject was 18 years or older at the time of procedure
- Subject who has undergone either laparoscopic or robotic-assisted RYGB or SG between the time frame of 30 days prior to institution's IRB approval date and the year 2017
- Subject has one of the below qualifications:
- Body mass index (BMI) \> 40 kg/m2 or more than 100 pounds overweight OR
- BMI \> 35 kg/m2 and one of the following obesity-related co-morbidities such as type II diabetes mellitus, hypertension, sleep apnea and other respiratory disorders, non- alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.
Exclusion
- Subject who underwent RYGB or SG as an emergent procedure
- Subject who underwent RYGB or SG as revisional bariatric procedure
- Subject who underwent RYGB or SG as a secondary (concomitant) procedure and not as a primary procedure
Key Trial Info
Start Date :
June 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 8 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05224791
Start Date
June 26 2020
End Date
April 8 2025
Last Update
March 28 2024
Active Locations (1)
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1
Minimally Invasive Surgical Associates, Methodist Dallas Medical Center
Dallas, Texas, United States, 75203