Prospective Robotic-assisted Revisional Bariatric Study

Intuitive Surgical100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Bariatric Surgery Candidate

Interventions

Revisional bariatric surgeryPROCEDURE

Subjects who undergo revisional bariatric surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Orlando Health

Orlando, Florida, United States

Outcomes

Primary Outcomes

Rate of conversions

Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery

Time frame: During the surgical procedure

Secondary Outcomes

Postoperative rate of anastomotic leak

Anastomotic leak is defined as a leak of luminal contents from a surgical join

Time frame: 45 days after date of procedure

Data from ClinicalTrials.gov

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