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

NCT05575947 | Completed FDA Device

• 1 other identifier: Bariatric Surgery
• Study Type: observational
• Target: 1,878
• Locations: 1 country
• Sites: 1

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).

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

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

Device: 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

Procedure: laparoscopic bariatric surgery

Interventions

da Vinci Surgical System DEVICE

da Vinci Surgical System

robotic-assisted

laparoscopic bariatric surgery PROCEDURE

laparoscopic bariatric surgery

laparoscopic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Intuitive Surgical

Sunnyvale, California, 94086, United States

Location

Study Officials

• Usha L Kreaden

  Intuitive Surgical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 12, 2022
• Study Start: May 1, 2022
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

US (1)