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

Bariatric Surgery Candidate Clinical Trial

Official title:

A Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch (DS) Bariatric Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575947
• Other study ID #: Bariatric Surgery
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: September 22, 2022

Study information

• Verified date: September 2023
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1878
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Device:
• da Vinci Surgical System
da Vinci Surgical System

Procedure:
• laparoscopic bariatric surgery
laparoscopic bariatric surgery

Locations

Country	Name	City	State
United States	Intuitive Surgical	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Complication Rates (Safety)	Incidence of complications occuring intraoperatively	Intraoperative
Primary	Transfusions (Safety)	Transfusion Rates Rate of transfusion that occur intraoperatively and postoperatively	perioperative
Primary	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)
Primary	30-Day Readmission Rates (Safety)	Incidence of readmission that occur after discharge	Upto 30 days
Primary	30-Day Reoperation Rates (Safety)	Incidence of reoperations that occur after till 30 days	upto 30 days following the documented date of the surgery
Primary	30-day Mortality Rate (Safety)	Incidence of mortality until 30 days	Intra-operative to 30-days
Primary	Conversion rate to open surgery (Effectiveness)	Incidence of conversion to open that occur intraoperatively	Intraoperative
Primary	Operative Time (Effectiveness)	Amount of time it takes to complete the procedure (in min)	Intraoperative
Primary	Length of hospital Stay (Effectiveness)	Number of days participant is in the hospital	perioperative