SurgeryNCT05211128
The Evolving Use of Robotic Surgery
An observational study of Surgery, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
A retrospective, population-based analysis examining the rates of robotic surgery between the years of 2009 - 2018. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Robotic Surgery, Open Surgery and Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 123,074 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2018to 1 Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Ontario adults that received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018.
Who may be able to join
- Minimum 18 years old
- Received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018
Who cannot join
- Non-Ontario residents
- Non-elective procedure
- Patients without OHIP eligibility
- Patients who had an identical procedure in the previous two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evolving Use of Robotic Surgery: A Population-based Analysis
A retrospective, population-based analysis examining the rates of robotic surgery between the years of 2009 - 2018.
Read the detailed description
A retrospective, population-based analysis examining the rates of robotic surgery in Ontario between the years of 2009 - 2018. The purposes of the study were (i) to describe temporal trends and (ii) patient- and system-level determinants of receiving robotic compared to open or laparoscopic surgery.
- Conditions
- Surgery
- Being tested
- Robotic Surgery, Open Surgery, Laparoscopic Surgery
- Keywords
- Robotic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic SurgeryProcedure or surgery
Surgical procedure using robotic technologies.
Open SurgeryProcedure or surgery
Surgical procedure using a large, open cut in the skin.
Laparoscopic SurgeryProcedure or surgery
Surgical procedure using small incisions and trochars.
| Study group | Role | What they receive |
|---|---|---|
| Radical prostatectomies | Not described Receives: Procedure: Robotic Surgery; Procedure: Open Surgery; Procedure: Laparoscopic Surgery | |
| Total hysterectomies | Not described Receives: Procedure: Robotic Surgery; Procedure: Open Surgery; Procedure: Laparoscopic Surgery | |
| Thoracic lobectomies | Not described Receives: Procedure: Robotic Surgery; Procedure: Open Surgery; Procedure: Laparoscopic Surgery | |
| Partial nephrectomies | Not described Receives: Procedure: Robotic Surgery; Procedure: Open Surgery; Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal trends
To describe temporal trends in robotic surgery
Measured: 2009 - 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jul 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123,074 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Unity Health Toronto, Western University, McMaster University, University of Ottawa, Saskatchewan Cancer Agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211128
- Sponsor's protocol ID
- 2019 0990 194 000
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evolving Use of Robotic Surgery: A Population-based Analysis
- ClinicalTrials.gov ID
- NCT05211128
- Acronym / sponsor ID
- 2019 0990 194 000
- Conditions
- Surgery
- Keywords
- Robotic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123,074 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Toronto, Unity Health Toronto, Western University, McMaster University, University of Ottawa, Saskatchewan Cancer Agency
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 27 Jan 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.
A retrospective, population-based analysis examining the rates of robotic surgery between the years of 2009 - 2018.
Detailed description
A retrospective, population-based analysis examining the rates of robotic surgery in Ontario between the years of 2009 - 2018. The purposes of the study were (i) to describe temporal trends and (ii) patient- and system-level determinants of receiving robotic compared to open or laparoscopic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Radical prostatectomies | – | Procedure: Robotic Surgery, Procedure: Open Surgery, Procedure: Laparoscopic Surgery |
| Total hysterectomies | – | Procedure: Robotic Surgery, Procedure: Open Surgery, Procedure: Laparoscopic Surgery |
| Thoracic lobectomies | – | Procedure: Robotic Surgery, Procedure: Open Surgery, Procedure: Laparoscopic Surgery |
| Partial nephrectomies | – | Procedure: Robotic Surgery, Procedure: Open Surgery, Procedure: Laparoscopic Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ontario adults that received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018.
Key inclusion criteria (2 listed)
- Minimum 18 years old
- Received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018
Key exclusion criteria (4 listed)
- Non-Ontario residents
- Non-elective procedure
- Patients without OHIP eligibility
- Patients who had an identical procedure in the previous two years
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 |
|---|---|---|
| Robotic SurgerySurgical procedure using robotic technologies. | Procedure or surgery | Partial nephrectomies, Radical prostatectomies, Thoracic lobectomies, Total hysterectomies |
| Open SurgerySurgical procedure using a large, open cut in the skin. | Procedure or surgery | Partial nephrectomies, Radical prostatectomies, Thoracic lobectomies, Total hysterectomies |
| Laparoscopic SurgerySurgical procedure using small incisions and trochars. | Procedure or surgery | Partial nephrectomies, Radical prostatectomies, Thoracic lobectomies, Total hysterectomies |
Primary outcome
Temporal trends
Time frame: 2009 - 2018
To describe temporal trends in robotic surgery
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 27 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 4 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 27 Jan 2022. 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 Canada. 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?
Temporal trends (time frame: 2009 - 2018). 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 27 Jan 2022.