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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04506190
Other study ID # ISI-dVBR-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date September 30, 2024

Study information

Verified date March 2024
Source Intuitive Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date September 30, 2024
Est. primary completion date March 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject is 18 years or older at the time of consent 2. Subject has a history of prior bariatric surgery 3. Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS) 4. Subject undergoes revisional bariatric surgery that is applicable to study Exclusion Criteria: 1. Subject is undergoing a primary bariatric procedure 2. Subject has undergone more than one previous bariatric procedure 3. Subject's revisional bariatric procedure is an emergent procedure 4. Subject is contraindicated for general anesthesia or surgery 5. Subject is unable to comply with the follow-up visit schedule 6. Subject is pregnant or suspects pregnancy 7. 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 8. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Revisional bariatric surgery
Subjects who undergo revisional bariatric surgery

Locations

Country Name City State
United States Orlando Health Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of conversions Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery During the surgical procedure
Secondary Postoperative rate of anastomotic leak Anastomotic leak is defined as a leak of luminal contents from a surgical join 45 days after date of procedure
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