Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical Procedures
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
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Intraoperative Complication Rates
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Transfusion Rates
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30-Day Post-Operative Complication Rates*
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30-Day Readmission Rates*
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30-Day Reoperation Rates*
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30-Day Mortality*
Effectiveness Related Outcomes
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Conversion Rate to Open Surgery
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Operative Time
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Length of Hospital Stay
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| robotic-assisted Robotic-assisted cases converted to open will be part of the robotic cohort. Comparison of the following safety and effectiveness related surgical outcomes across robotic-assisted and laparoscopic cohorts: Safety Related Outcomes Intraoperative Complication Rates Transfusion Rates 30-Day Post-Operative Complication Rates 30-Day Readmission Rates 30-Day Reoperation Rates 30-Day Mortality Effectiveness Related Outcomes Conversion Rate to Open Surgery Operative Time Length of Hospital Stay |
Device: da Vinci Surgical System
da Vinci Surgical System
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| laparoscopic Laparoscopic cases converted to open will be part of the laparoscopic cohort. Comparison of the following safety and effectiveness related surgical outcomes across robotic-assisted and laparoscopic cohorts: Safety Related Outcomes Intraoperative Complication Rates Transfusion Rates 30-Day Post-Operative Complication Rates 30-Day Readmission Rates 30-Day Reoperation Rates 30-Day Mortality Effectiveness Related Outcomes Conversion Rate to Open Surgery Operative Time Length of Hospital Stay |
Procedure: laparoscopic bariatric surgery
laparoscopic bariatric surgery
|
Outcome Measures
Primary Outcome Measures
- Intraoperative Complication Rates (Safety) [Intraoperative]
Incidence of complications occuring intraoperatively
- Transfusions (Safety) [perioperative]
Transfusion Rates Rate of transfusion that occur intraoperatively and postoperatively
- 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 Readmission Rates (Safety) [Upto 30 days]
Incidence of readmission that occur after discharge
- 30-Day Reoperation Rates (Safety) [upto 30 days following the documented date of the surgery]
Incidence of reoperations that occur after till 30 days
- 30-day Mortality Rate (Safety) [Intra-operative to 30-days]
Incidence of mortality until 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
Eligibility Criteria
Criteria
Inclusion Criteria-
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Patients who are ≥ 18 years old and had a primary laparoscopic or robotic-assisted bariatric surgery procedure with a duodenal switch (DS) defined herein as BPD-DS, SADI-S, or OADS; and,
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Met one of the below qualifications:
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Body mass index (BMI) > 40 kg/m2 OR
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BMI > 35 kg/m2 and had one of the following obesity-related co-morbidities such as type II diabetes mellitus, hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease according to the US Centers of Medicare & Medicaid Services (CMS) criteria for the use of bariatric surgery in adults
Exclusion Criteria-
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Were diagnosed with cancer; or
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Underwent an outpatient DS bariatric surgical procedure; or
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Underwent an emergent DS bariatric surgical procedure; or
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Underwent a DS procedure concomitant to a different primary procedure (i.e., colon resection)
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Underwent a revisional DS bariatric surgical procedure (i.e., patient had a prior bariatric procedure within three (3) years of the DS procedure)
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Have missing operating room (OR) time data (i.e., incomplete billing record)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Intuitive Surgical | Sunnyvale | California | United States | 94086 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
- Study Director: Usha L Kreaden, Intuitive Surgical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Bariatric Surgery