Prospective Robotic-assisted Revisional Bariatric Study

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.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orlando Health

Orlando, Florida, 32806, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Revisional bariatric surgery

Procedure

Subjects who undergo revisional bariatric surgery

Primary outcomes

Rate of conversions

Time frame: During the surgical procedure

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

Secondary outcomes

Postoperative rate of anastomotic leak

Time frame: 45 days after date of procedure

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

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Robotic-assisted Revisional Bariatric Surgery

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2024
First posted: Aug 10, 2020
Registry last updated: Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed