Prospective Robotic-assisted Revisional Bariatric Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04506190

Enrollment

100

Registered

2020-08-10

Start date

2020-11-01

Completion date

2024-09-30

Last updated

2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

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.

Interventions

PROCEDURERevisional bariatric surgery

Subjects who undergo revisional bariatric surgery

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026