Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical Procedures
NCT ID: NCT05575947
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1878 participants
OBSERVATIONAL
2022-05-01
2022-09-22
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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
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
da Vinci Surgical System
da Vinci Surgical System
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
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
laparoscopic bariatric surgery
laparoscopic bariatric surgery
Interventions
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da Vinci Surgical System
da Vinci Surgical System
laparoscopic bariatric surgery
laparoscopic bariatric surgery
Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Principal Investigators
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Usha L Kreaden
Role: STUDY_DIRECTOR
Intuitive Surgical
Locations
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Intuitive Surgical
Sunnyvale, California, United States
Countries
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Other Identifiers
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Bariatric Surgery
Identifier Type: -
Identifier Source: org_study_id
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