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Completed

NCT Number: NCT05575947

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

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).

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intuitive Surgical

Sunnyvale, California, 94086, United States

About this study

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

  • Intraoperative Complication Rates
  • Transfusion Rates
  • 30-Day Post-Operative Complication Rates*
  • 30-Day Readmission Rates*
  • 30-Day Reoperation Rates*
  • 30-Day Mortality*

Effectiveness Related Outcomes

  • Conversion Rate to Open Surgery
  • Operative Time
  • Length of Hospital Stay

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • 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

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)

Treatment and study plan

da Vinci Surgical System

Device

da Vinci Surgical System

Laparoscopic Bariatric Surgery

Procedure

laparoscopic bariatric surgery

Primary outcomes

  1. Intraoperative Complication Rates (Safety)

    Time frame: Intraoperative

    Incidence of complications occuring intraoperatively

  2. Transfusions (Safety)

    Time frame: perioperative

    Transfusion Rates Rate of transfusion that occur intraoperatively and postoperatively

  3. 30-Day Post-Operative Complication Rates (Safety)

    Time frame: Intraoperative to 30-days (from the date of surgery upto 30-days)

    Incidence of complications that occur after surgery to 30-days

  4. 30-Day Readmission Rates (Safety)

    Time frame: Upto 30 days

    Incidence of readmission that occur after discharge

  5. 30-Day Reoperation Rates (Safety)

    Time frame: upto 30 days following the documented date of the surgery

    Incidence of reoperations that occur after till 30 days

  6. 30-day Mortality Rate (Safety)

    Time frame: Intra-operative to 30-days

    Incidence of mortality until 30 days

  7. Conversion rate to open surgery (Effectiveness)

    Time frame: Intraoperative

    Incidence of conversion to open that occur intraoperatively

  8. Operative Time (Effectiveness)

    Time frame: Intraoperative

    Amount of time it takes to complete the procedure (in min)

  9. Length of hospital Stay (Effectiveness)

    Time frame: perioperative

    Number of days participant is in the hospital

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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