Prospective Robotic-assisted Revisional Bariatric Study

March 6, 2024 updated by: Intuitive Surgical

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic-assisted revisional bariatric surgery
Subjects who undergo robotic-assisted revisional bariatric surgery
Procedure: Revisional bariatric surgery
Subjects who undergo revisional bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
45 days after date of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

March 15, 2022

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ISI-dVBR-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All individual participant data that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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