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Clinical Trials/NCT04329780
NCT04329780
Completed
N/A

Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastric Bypass and Sleeve Gastrectomy

Intuitive Surgical1 site in 1 country1,872 target enrollmentApril 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
Intuitive Surgical
Enrollment
1872
Locations
1
Primary Endpoint
Perioperative complications
Status
Completed
Last Updated
last year

Overview

Brief Summary

A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
March 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years or older at the time of procedure
  • Undergone either laparoscopic or robotic-assisted Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
  • Meets qualification for primary bariatric procedure per American Society for Metabolic and Bariatric Surgery guidelines

Exclusion Criteria

  • Subject who underwent bariatric procedure as an emergency procedure
  • Subject who underwent bariatric procedure as an revisional bariatric procedure
  • Subject who underwent bariatric procedure as an secondary procedure

Outcomes

Primary Outcomes

Perioperative complications

Time Frame: 30 days after surgery

Peri-operative complications include adverse events during the Intra-operative and post-operative periods.

Study Sites (1)

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