Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG

NCT04329780 | Completed

• 1 other identifier: ISI-dVBAR-001
• Study Type: observational
• Target: 1,872
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Perioperative complications

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

  30 days after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who meets all inclusion and exclusion criteria and who have undergone a primary bariatric procedure.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: April 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 30, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)