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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).
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
Effectiveness Related Outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
Effectiveness Related Outcomes
|
| |
| 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
Effectiveness Related Outcomes
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci Surgical System | Device | da Vinci Surgical System |
| |
| 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) |
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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:
Exclusion Criteria-
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All patients meeting the inclusion/exclusion criteria iwho underwent DS Bariatric Surgical Procedures between January 1, 2016 and December 31, 2020 will be included. Acute and 30-day follow up data will be included in this analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Usha L Kreaden | Intuitive Surgical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intuitive Surgical | Sunnyvale | California | 94086 | United States |
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| laparoscopic bariatric surgery |
| Procedure |
laparoscopic bariatric surgery |
|
| Intraoperative |
| Length of hospital Stay (Effectiveness) | Number of days participant is in the hospital | perioperative |