Prospective Robotic-assisted Revisional Bariatric Study

NCT ID: NCT04506190

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery Candidate

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Robotic-assisted revisional bariatric surgery

Subjects who undergo robotic-assisted revisional bariatric surgery

Revisional bariatric surgery

Intervention Type PROCEDURE

Subjects who undergo revisional bariatric surgery

Interventions

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Revisional bariatric surgery

Subjects who undergo revisional bariatric surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orlando Health

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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ISI-dVBR-002

Identifier Type: -

Identifier Source: org_study_id

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