Prospective Robotic-assisted Revisional Bariatric Study

Completed

• Conditions: Bariatric Surgery Candidate
• Interventions: Procedure: Revisional bariatric surgery

• Registration Number: NCT04506190
• Lead Sponsor: Intuitive Surgical

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-10
• Study Start: 2020-11-01
• Primary Completion: 2022-03-15
• Study Completion: 2024-09-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic-assisted revisional bariatric surgery	Revisional bariatric surgery	Subjects who undergo robotic-assisted revisional bariatric surgery

Primary Outcome Measures

Name	Time	Method
Rate of conversions	During the surgical procedure	Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative rate of anastomotic leak	45 days after date of procedure	Anastomotic leak is defined as a leak of luminal contents from a surgical join

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States