Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG

Active, not recruiting

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT04329780
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study Start: 2020-04-01
• Study First Posted: 2020-04-01
• Primary Completion: 2022-03-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1872

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States