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NCT04329780 Clinical Trial

Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG

Bariatric Surgery Candidate Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04329780
Other study ID # ISI-dVBAR-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date September 30, 2024

Study information
Verified date March 2024
Source Intuitive Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1872
Est. completion date September 30, 2024
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

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 Perioperative complications Peri-operative complications include adverse events during the Intra-operative and post-operative periods. 30 days after surgery
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