Prospective Robotic-assisted Revisional Bariatric Study

Intuitive Surgical

Status: Completed

Conditions: Bariatric Surgery Candidate

Treatments: Procedure: Revisional bariatric surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT04506190

ISI-dVBR-002

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Robotic-assisted revisional bariatric surgery

Description:

Subjects who undergo robotic-assisted revisional bariatric surgery

Treatment:

Procedure: Revisional bariatric surgery