MedPath

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

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
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (1)

Intuitive Surgical

🇺🇸

Sunnyvale, California, United States

Intuitive Surgical
🇺🇸Sunnyvale, California, United States

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