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

Study Overview
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Brief Summary
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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
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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 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

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

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Device: da Vinci Surgical System
* Procedure: laparoscopic bariatric surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria- 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, Met one of the below qualifications: Body mass index (BMI) > 40 kg/m2 OR 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- Were diagnosed with cancer; or Underwent an outpatient DS bariatric surgical procedure; or Underwent an emergent DS bariatric surgical procedure; or Underwent a DS procedure concomitant to a different primary procedure (i.e., colon resection) Underwent a revisional DS bariatric surgical procedure (i.e., patient had a prior bariatric procedure within three (3) years of the DS procedure) Have missing operating room (OR) time data (i.e., incomplete billing record)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| robotic-assisted<br>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<br>* da Vinci Surgical System<br>|
| laparoscopic<br>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<br>* laparoscopic bariatric surgery<br>|

What is the study measuring?
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Primary Outcome Measures

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