NCT05575947

Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical Procedures

A Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch (DS) Bariatric Surgical Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,878 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

To compare the safety and effectiveness of robotic-assisted Duodenal-Switch Bariatric Surgical Procedures (including Biliopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis- Duodeno Ileal Bypass with Sleeve/SADI-S, and One Anastomosis Duodenal Switch/OADS) with laparoscopic approaches using real world data (RWD) from the Premier Healthcare Database (PHD).

Detailed description

To compare the safety and effectiveness of robotic-assisted Duodenal-Switch Bariatric Surgical Procedures (including Biliopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis- Duodeno Ileal Bypass with Sleeve/SADI-S, and One Anastomosis Duodenal Switch/OADS) with laparoscopic approaches using real world data (RWD) from the Premier Healthcare Database (PHD). The study endpoints include: Safety Related Outcomes 1. Intraoperative Complication Rates 2. Transfusion Rates 3. 30-Day Post-Operative Complication Rates\* 4. 30-Day Readmission Rates\* 5. 30-Day Reoperation Rates\* 6. 30-Day Mortality\* Effectiveness Related Outcomes 1. Conversion Rate to Open Surgery 2. Operative Time 3. Length of Hospital Stay

Conditions

• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DEVICE	da Vinci Surgical System	da Vinci Surgical System
PROCEDURE	laparoscopic bariatric surgery	laparoscopic bariatric surgery

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2022-10-12
• Last updated: 2023-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study