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

Completed

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT05575947
• Lead Sponsor: Intuitive Surgical

Brief 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

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-09-20
• Primary Completion: 2022-09-22
• Study Completion: 2022-09-22
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1878

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transfusions (Safety)	perioperative	Transfusion Rates Rate of transfusion that occur intraoperatively and postoperatively
30-Day Readmission Rates (Safety)	Upto 30 days	Incidence of readmission that occur after discharge
Intraoperative Complication Rates (Safety)	Intraoperative	Incidence of complications occuring intraoperatively
30-Day Post-Operative Complication Rates (Safety)	Intraoperative to 30-days (from the date of surgery upto 30-days)	Incidence of complications that occur after surgery to 30-days
30-Day Reoperation Rates (Safety)	upto 30 days following the documented date of the surgery	Incidence of reoperations that occur after till 30 days
Conversion rate to open surgery (Effectiveness)	Intraoperative	Incidence of conversion to open that occur intraoperatively
Operative Time (Effectiveness)	Intraoperative	Amount of time it takes to complete the procedure (in min)
Length of hospital Stay (Effectiveness)	perioperative	Number of days participant is in the hospital
30-day Mortality Rate (Safety)	Intra-operative to 30-days	Incidence of mortality until 30 days

Trial Locations

Locations (1)

Intuitive Surgical; 🇺🇸 Sunnyvale, California, United States