Bariatric Surgery Candidate
Conditions
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
Interventions
DEVICEda Vinci Surgical System
da Vinci Surgical System
PROCEDURElaparoscopic bariatric surgery
laparoscopic bariatric surgery
Sponsors
Intuitive Surgical
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
- 1. 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, 2. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed