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

Intuitive Surgical

Status: Completed

Conditions: Bariatric Surgery Candidate

Treatments: Device: da Vinci Surgical System; Procedure: laparoscopic bariatric surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05575947

Bariatric Surgery

Details and patient eligibility

About

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).

Full 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

Enrollment: 1,878 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

1,878 participants in 2 patient groups

robotic-assisted

Description:

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

Treatment:

Device: da Vinci Surgical System

laparoscopic

Description:

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

Treatment:

Procedure: laparoscopic bariatric surgery