Bariatric Surgery CandidateNCT05575947
Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical Procedures
An observational study of Bariatric Surgery Candidate, run by Intuitive Surgical at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- da Vinci Surgical System and laparoscopic bariatric surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,878 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 22 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch (DS) 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).
Read the 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
- 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
- Conditions
- Bariatric Surgery Candidate
- Being tested
- da Vinci Surgical System, laparoscopic bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Surgical SystemDevice
da Vinci Surgical System
laparoscopic bariatric surgeryProcedure or surgery
laparoscopic bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: laparoscopic bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Complication Rates (Safety)
Incidence of complications occuring intraoperatively
Measured: Intraoperative
Transfusions (Safety)
Transfusion Rates Rate of transfusion that occur intraoperatively and postoperatively
Measured: perioperative
30-Day Post-Operative Complication Rates (Safety)
Incidence of complications that occur after surgery to 30-days
Measured: Intraoperative to 30-days (from the date of surgery upto 30-days)
30-Day Readmission Rates (Safety)
Incidence of readmission that occur after discharge
Measured: Upto 30 days
30-Day Reoperation Rates (Safety)
Incidence of reoperations that occur after till 30 days
Measured: upto 30 days following the documented date of the surgery
30-day Mortality Rate (Safety)
Incidence of mortality until 30 days
Measured: Intra-operative to 30-days
Conversion rate to open surgery (Effectiveness)
Incidence of conversion to open that occur intraoperatively
Measured: Intraoperative
Operative Time (Effectiveness)
Amount of time it takes to complete the procedure (in min)
Measured: Intraoperative
Length of hospital Stay (Effectiveness)
Number of days participant is in the hospital
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 May 2022
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Usha L Kreaden, Study director, Intuitive Surgical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575947
- Sponsor's protocol ID
- Bariatric Surgery
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch (DS) Bariatric Surgical Procedures
- ClinicalTrials.gov ID
- NCT05575947
- Acronym / sponsor ID
- Bariatric Surgery
- Conditions
- Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,878 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic-assisted | – | Device: da Vinci Surgical SystemRobotic-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 |
| laparoscopic | – | Procedure: laparoscopic bariatric surgeryLaparoscopic 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| da Vinci Surgical Systemda Vinci Surgical System | Device | robotic-assisted |
| laparoscopic bariatric surgerylaparoscopic bariatric surgery | Procedure or surgery | laparoscopic |
Primary outcome
Intraoperative Complication Rates (Safety)
Time frame: Intraoperative
Incidence of complications occuring intraoperatively
Transfusions (Safety)
Time frame: perioperative
Transfusion Rates Rate of transfusion that occur intraoperatively and postoperatively
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
30-Day Readmission Rates (Safety)
Time frame: Upto 30 days
Incidence of readmission that occur after discharge
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
30-day Mortality Rate (Safety)
Time frame: Intra-operative to 30-days
Incidence of mortality until 30 days
Conversion rate to open surgery (Effectiveness)
Time frame: Intraoperative
Incidence of conversion to open that occur intraoperatively
Operative Time (Effectiveness)
Time frame: Intraoperative
Amount of time it takes to complete the procedure (in min)
Length of hospital Stay (Effectiveness)
Time frame: perioperative
Number of days participant is in the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Usha L Kreaden study director
Intuitive Surgical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate, run by Intuitive Surgical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Complication Rates (Safety) (time frame: Intraoperative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.