Prospective Robotic-assisted Revisional Bariatric Study

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04506190
• Other study ID #: ISI-dVBR-002
• Status: Active, not recruiting
• Start date: November 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• Revisional bariatric surgery
Subjects who undergo revisional bariatric surgery

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of conversions	Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery	During the surgical procedure
Secondary	Postoperative rate of anastomotic leak	Anastomotic leak is defined as a leak of luminal contents from a surgical join	45 days after date of procedure