Renal MassesCONVERTNCT04011891
Comparison of OpeN VErsus RoboTic Partial Nephrectomy
A study testing Robotic Partial Nephrectomy and Open Partial Nephrectomy in people with Renal Masses, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
A prospective randomized controlled feasibility trial for patients undergoing partial nephrectomy for T1 renal masses at Princess Margaret. Participants will be randomized receive either open or robotic partial nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Masses
- What is being tested?
- Robotic Partial Nephrectomy and Open Partial Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 24 Jul 2023
- Phase
- Interventional
- 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
Who may be able to join
- Radiologically characterized T1 renal mass
- Elected for partial nephrectomy surgery
- Under the care of a uro-oncologist at Princess Margaret Cancer Centre
- Willing to comply with follow-up protocol
- Capable of providing informed consent
Who cannot join
- Radiologically characterized tumours ≥ T1
- Unfit for general anesthetic
- Unsuitable for robotic surgery (determined by treating physician)
- Unwilling to comply with standardized follow-up protocol
- Evidence of metastatic disease
- Solitary kidney
Show all 11Show fewer
- Previous surgery on affected kidney
- Multiple tumours
- Known genetic syndromes predisposing to multiple renal tumours (e.g., VHL, TS, BHD)
- Pregnancy
- Inability to read, understand, and complete the questionnaires written in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of OpeN VErsus RoboTic Partial Nephrectomy Trial - a Feasibility Randomized Controlled Trial
A prospective randomized controlled feasibility trial for patients undergoing partial nephrectomy for T1 renal masses at Princess Margaret. Participants will be randomized receive either open or robotic partial nephrectomy.
Read the detailed description
This is an interventional, unblinded RCT where a total of 30 patients who have consented to undergo partial nephrectomy for a T1 renal mass under the care of a uro-oncologist at Princess Margaret Cancer Centre will be randomized 1:1 to one of two arms:
Arm A: Robotic Partial Nephrectomy Arm B: Open Partial Nephrectomy
Patients will complete all pre-admission testing as per standard of care, regardless of arm allocation. Creatinine and eGFR are measured routinely pre-operatively and these values will be used as a baseline for all patients. In addition to standard pre-admission testing, participants will complete the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) offered either on paper at the visit or online via an emailed link.
Following either open or robotic partial nephrectomy, participants will be followed as per standard of care. Generally, this includes follow-up at 4-6 weeks, 6 months, 12 months and then either every 6 months thereafter or yearly, depending on pathology. All clinical outcome measures for this study are routinely reported post-operatively and in the follow-up period for partial nephrectomy patients. Quality of life will be assessed at the 4-7 week and 6 month follow-up visits using the EORTC QLQ-C30 offered either on paper at the visit or online via an emailed link. Participants will also be asked to complete a Surgical Recovery/Flank Bulge questionnaire regarding their incision healing and recovery from surgery at the 6-month follow-up visit.
The primary objective of this study is to assess the feasibility of a full RCT comparing perioperative outcomes in patients undergoing robotic vs. open partial nephrectomy at the investigator's institution.
The secondary objective of the study is to compare pilot outcome measures addressing oncologic, functional, and health economics outcomes to assess whether a full RCT is worthwhile and feasible.
- Conditions
- Renal Masses
- Being tested
- Robotic Partial Nephrectomy, Open Partial Nephrectomy
- Keywords
- Minimally Invasive Surgery, Robotic Surgery, Partial Nephrectomy, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Partial NephrectomyProcedure or surgery
Robotic partial nephrectomy using da Vinci robot.
Open Partial NephrectomyProcedure or surgery
Standard open partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic Partial Nephrectomy | Active comparator | Partial nephrectomy performed using the DaVinci robotic surgical system. Receives: Procedure: Robotic Partial Nephrectomy |
| Open Partial Nephrectomy | Active comparator | Partial nephrectomy performed using the open approach. Receives: Procedure: Open Partial Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Potential
Rate of accrual [participants per month]
Measured: Study duration (2 years)
Suitability of secondary outcome measures
Assess the feasibility of collecting all secondary outcome data. To be assessed qualitatively by the study team and by calculating the proportion of patients with each data point completed.
Measured: Study duration (2 years)
Resource Utilization - Operating Room/Robotic Studio Time Availability
Assess the capacity of accommodating surgical time for a full scale clinical trial. Measured by time from decision to treat to surgery date.
Measured: Study duration (2 years)
Resource Utilization - Cost of Study Participation
To develop an accurate budget for a full trail, we are assessing the average cost of running the trial per patient, per arm. This calculation will include: cost of study coordinator time (number of hours x hourly wage), additional cost of robotic disposables, and cost of additional testing outside of standard of care.
Measured: Study duration (2 years)
Secondary outcomes (13)
Operative Time
Operative time in minutes
Measured: Duration of surgery
Warm Ischemia Time
Measured in minutes from the time of application of first vascular clamp to removal of clamp
Measured: Duration of surgery
Blood Loss
Estimated blood loss (mL), transfusion rates, use of hemostatic agents (which agents and how many used)
Measured: Duration of surgery
Conversion rate to radical nephrectomy or open partial nephrectomy
Time in minutes from the start of robotic partial nephrectomy to the time decision was made to convert
Measured: Duration of surgery
Length of Stay
Calculated from day of admission to day of discharge
Measured: 1-7 days
Complication Rates
Clavien-Dindo classification and need for/extent of re-intervention
Measured: Up to 6 months post-surgery
Renal Function
Creatinine and eGFR measured pre-op, day 1 post-op, 4-7 weeks post-op, 6 months post-op
Measured: Up to 6 months post-surgery
Positive margin rate
Frequency of positive margins as reported in the final pathology report.
Measured: 1-3 weeks post-operatively
Margin size
Distance from tumour to surgical margin (mm) as reported in final pathology report.
Measured: 1-3 weeks post-operatively
Analgesic Requirements
use of epidural, PCA, or oral analgesia
Measured: Up to 6 months post-operatively
Quality of Life: EORTC QLQ-C30
Measured using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at 4-7 weeks and 6 months post-operatively
Measured: Up to 6 months post-operatively
Surgical Recovery/Flank Bulge
Surveyed at 6 months post-operatively
Measured: 6 months from surgical date
Health Economics
Estimated overall cost of surgery for each arm (surgical supplies, length of stay, etc.) and cost of post-operative readmissions and ER visits
Measured: Study duration (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Nov 2019
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Why it stopped: The Ontario government is now funding robotic partial nephrectomies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal MassesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011891
- Sponsor's protocol ID
- 18-5885
- Acronym
- CONVERT
- Status last verified
- Jul 2023
- First submitted
- 20 May 2019
- Last updated
- 27 Jul 2023
- 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 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of OpeN VErsus RoboTic Partial Nephrectomy Trial - a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04011891
- Acronym / sponsor ID
- CONVERT / 18-5885
- Conditions
- Renal Masses
- Keywords
- Minimally Invasive Surgery, Robotic Surgery, Partial Nephrectomy, Feasibility
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Ontario government is now funding robotic partial nephrectomies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 9 Jul 2019 (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 prospective randomized controlled feasibility trial for patients undergoing partial nephrectomy for T1 renal masses at Princess Margaret. Participants will be randomized receive either open or robotic partial nephrectomy.
Detailed description
This is an interventional, unblinded RCT where a total of 30 patients who have consented to undergo partial nephrectomy for a T1 renal mass under the care of a uro-oncologist at Princess Margaret Cancer Centre will be randomized 1:1 to one of two arms:
Arm A: Robotic Partial Nephrectomy Arm B: Open Partial Nephrectomy
Patients will complete all pre-admission testing as per standard of care, regardless of arm allocation. Creatinine and eGFR are measured routinely pre-operatively and these values will be used as a baseline for all patients. In addition to standard pre-admission testing, participants will complete the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) offered either on paper at the visit or online via an emailed link.
Following either open or robotic partial nephrectomy, participants will be followed as per standard of care. Generally, this includes follow-up at 4-6 weeks, 6 months, 12 months and then either every 6 months thereafter or yearly, depending on pathology. All clinical outcome measures for this study are routinely reported post-operatively and in the follow-up period for partial nephrectomy patients. Quality of life will be assessed at the 4-7 week and 6 month follow-up visits using the EORTC QLQ-C30 offered either on paper at the visit or online via an emailed link. Participants will also be asked to complete a Surgical Recovery/Flank Bulge questionnaire regarding their incision healing and recovery from surgery at the 6-month follow-up visit.
The primary objective of this study is to assess the feasibility of a full RCT comparing perioperative outcomes in patients undergoing robotic vs. open partial nephrectomy at the investigator's institution.
The secondary objective of the study is to compare pilot outcome measures addressing oncologic, functional, and health economics outcomes to assess whether a full RCT is worthwhile and feasible.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Partial Nephrectomy | Active comparator | Procedure: Robotic Partial NephrectomyPartial nephrectomy performed using the DaVinci robotic surgical system. |
| Open Partial Nephrectomy | Active comparator | Procedure: Open Partial NephrectomyPartial nephrectomy performed using the open approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiologically characterized T1 renal mass
- Elected for partial nephrectomy surgery
- Under the care of a uro-oncologist at Princess Margaret Cancer Centre
- Willing to comply with follow-up protocol
- Capable of providing informed consent
Key exclusion criteria (11 listed)
- Radiologically characterized tumours ≥ T1
- Unfit for general anesthetic
- Unsuitable for robotic surgery (determined by treating physician)
- Unwilling to comply with standardized follow-up protocol
- Evidence of metastatic disease
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 Partial NephrectomyRobotic partial nephrectomy using da Vinci robot. | Procedure or surgery | Robotic Partial Nephrectomy |
| Open Partial NephrectomyStandard open partial nephrectomy | Procedure or surgery | Open Partial Nephrectomy |
Primary outcome
Recruitment Potential
Time frame: Study duration (2 years)
Rate of accrual [participants per month]
Suitability of secondary outcome measures
Time frame: Study duration (2 years)
Assess the feasibility of collecting all secondary outcome data. To be assessed qualitatively by the study team and by calculating the proportion of patients with each data point completed.
Resource Utilization - Operating Room/Robotic Studio Time Availability
Time frame: Study duration (2 years)
Assess the capacity of accommodating surgical time for a full scale clinical trial. Measured by time from decision to treat to surgery date.
Resource Utilization - Cost of Study Participation
Time frame: Study duration (2 years)
To develop an accurate budget for a full trail, we are assessing the average cost of running the trial per patient, per arm. This calculation will include: cost of study coordinator time (number of hours x hourly wage), additional cost of robotic disposables, and cost of additional testing outside of standard of care.
13 secondary outcomes
Operative Time
Time frame: Duration of surgery
Warm Ischemia Time
Time frame: Duration of surgery
Blood Loss
Time frame: Duration of surgery
Conversion rate to radical nephrectomy or open partial nephrectomy
Time frame: Duration of surgery
Length of Stay
Time frame: 1-7 days
Complication Rates
Time frame: Up to 6 months post-surgery
Renal Function
Time frame: Up to 6 months post-surgery
Positive margin rate
Time frame: 1-3 weeks post-operatively
Margin size
Time frame: 1-3 weeks post-operatively
Analgesic Requirements
Time frame: Up to 6 months post-operatively
Quality of Life: EORTC QLQ-C30
Time frame: Up to 6 months post-operatively
Surgical Recovery/Flank Bulge
Time frame: 6 months from surgical date
Health Economics
Time frame: Study duration (2 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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.
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?
A study testing Robotic Partial Nephrectomy and Open Partial Nephrectomy in people with Renal Masses, run by University Health Network, Toronto 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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 27 Jul 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Recruitment Potential (time frame: Study duration (2 years)). The study lists 4 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 27 Jul 2023.