Prospective Robotic-assisted Revisional Bariatric Study

NCT04506190 | Completed

• 1 other identifier: ISI-dVBR-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative rate of anastomotic leak

  45 days after date of procedure

Study Arms (1)

Robotic-assisted revisional bariatric surgery

Subjects who undergo robotic-assisted revisional bariatric surgery

Procedure: Revisional bariatric surgery

Interventions

Revisional bariatric surgery PROCEDURE

Subjects who undergo revisional bariatric surgery

Robotic-assisted revisional bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who have had one previous bariatric surgery, are undergoing a revisional bariatric surgery applicable to this study, and who are deemed qualified by study inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: November 1, 2020
• Primary Completion: March 15, 2022
• Study Completion: September 30, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)