Clinical trial NCT05575947: Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical Procedures
Official title: A Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch (DS) Bariatric Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 1878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Intraoperative Complication Rates (Safety)
timeFrame: Intraoperative
measure: Transfusions (Safety)
timeFrame: perioperative
measure: 30-Day Post-Operative Complication Rates (Safety)
timeFrame: Intraoperative to 30-days (from the date of surgery upto 30-days)
measure: 30-Day Readmission Rates (Safety)
timeFrame: Upto 30 days
measure: 30-Day Reoperation Rates (Safety)
timeFrame: upto 30 days following the documented date of the surgery
measure: 30-day Mortality Rate (Safety)
timeFrame: Intra-operative to 30-days
measure: Conversion rate to open surgery (Effectiveness)
timeFrame: Intraoperative
measure: Operative Time (Effectiveness)
timeFrame: Intraoperative
measure: Length of hospital Stay (Effectiveness)
timeFrame: perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Intuitive Surgical
state: California
Study officials:
affiliation: Intuitive Surgical
name: Usha L Kreaden
role: STUDY_DIRECTOR
References: