Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical Procedures
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1878
Not provided
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Intuitive Surgical
🇺🇸Sunnyvale, California, United States
Intuitive Surgical🇺🇸Sunnyvale, California, United States