Status:
COMPLETED
Prospective Robotic-assisted Revisional Bariatric Study
Lead Sponsor:
Intuitive Surgical
Conditions:
Bariatric Surgery Candidate
Eligibility:
All Genders
18+ years
Brief Summary
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes o...
Eligibility Criteria
Inclusion
- Subject is 18 years or older at the time of consent
- Subject has a history of prior bariatric surgery
- Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS)
- Subject undergoes revisional bariatric surgery that is applicable to study
Exclusion
- Subject is undergoing a primary bariatric procedure
- Subject has undergone more than one previous bariatric procedure
- Subject's revisional bariatric procedure is an emergent procedure
- Subject is contraindicated for general anesthesia or surgery
- Subject is unable to comply with the follow-up visit schedule
- Subject is pregnant or suspects pregnancy
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04506190
Start Date
November 1 2020
End Date
September 30 2024
Last Update
April 13 2025
Active Locations (1)
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1
Orlando Health
Orlando, Florida, United States, 32806