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出境医 / 临床实验 / Comparison of OpeN VErsus RoboTic Partial Nephrectomy (CONVERT)

Comparison of OpeN VErsus RoboTic Partial Nephrectomy (CONVERT)

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Renal Masses Procedure: Robotic Partial Nephrectomy Procedure: Open Partial Nephrectomy Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of OpeN VErsus RoboTic Partial Nephrectomy Trial - a Feasibility Randomized Controlled Trial
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Robotic Partial Nephrectomy
Partial nephrectomy performed using the DaVinci robotic surgical system.
Procedure: Robotic Partial Nephrectomy
Robotic partial nephrectomy using da Vinci robot.

Active Comparator: Open Partial Nephrectomy
Partial nephrectomy performed using the open approach.
Procedure: Open Partial Nephrectomy
Standard open partial nephrectomy

Outcome Measures
Primary Outcome Measures :
  1. Recruitment Potential [ Time Frame: Study duration (2 years) ]
    Rate of accrual [participants per month]

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Operative Time [ Time Frame: Duration of surgery ]
    Operative time in minutes

  2. Warm Ischemia Time [ Time Frame: Duration of surgery ]
    Measured in minutes from the time of application of first vascular clamp to removal of clamp

  3. Blood Loss [ Time Frame: Duration of surgery ]
    Estimated blood loss (mL), transfusion rates, use of hemostatic agents (which agents and how many used)

  4. Conversion rate to radical nephrectomy or open partial nephrectomy [ Time Frame: Duration of surgery ]
    Time in minutes from the start of robotic partial nephrectomy to the time decision was made to convert

  5. Length of Stay [ Time Frame: 1-7 days ]
    Calculated from day of admission to day of discharge

  6. Complication Rates [ Time Frame: Up to 6 months post-surgery ]
    Clavien-Dindo classification and need for/extent of re-intervention

  7. Renal Function [ Time Frame: Up to 6 months post-surgery ]
    Creatinine and eGFR measured pre-op, day 1 post-op, 4-7 weeks post-op, 6 months post-op

  8. Positive margin rate [ Time Frame: 1-3 weeks post-operatively ]
    Frequency of positive margins as reported in the final pathology report.

  9. Margin size [ Time Frame: 1-3 weeks post-operatively ]
    Distance from tumour to surgical margin (mm) as reported in final pathology report.

  10. Analgesic Requirements [ Time Frame: Up to 6 months post-operatively ]
    use of epidural, PCA, or oral analgesia

  11. Quality of Life: EORTC QLQ-C30 [ Time Frame: Up to 6 months post-operatively ]
    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

  12. Surgical Recovery/Flank Bulge [ Time Frame: 6 months from surgical date ]
    Surveyed at 6 months post-operatively

  13. Health Economics [ Time Frame: Study duration (2 years) ]
    Estimated overall cost of surgery for each arm (surgical supplies, length of stay, etc.) and cost of post-operative readmissions and ER visits


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Robert Hamilton, MD 416-946-2909 rob.hamilton@uhn.ca
Contact: Kopika Kuhathaas, BSc 416-946-2282 kopika.kuhathaas@uhn.ca

Locations
Layout table for location information
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Robert Hamilton, MD    416-946-2909      
Sponsors and Collaborators
University Health Network, Toronto
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • Operative Time [ Time Frame: Duration of surgery ]
    Operative time in minutes
  • Warm Ischemia Time [ Time Frame: Duration of surgery ]
    Measured in minutes from the time of application of first vascular clamp to removal of clamp
  • Blood Loss [ Time Frame: Duration of surgery ]
    Estimated blood loss (mL), transfusion rates, use of hemostatic agents (which agents and how many used)
  • Conversion rate to radical nephrectomy or open partial nephrectomy [ Time Frame: Duration of surgery ]
    Time in minutes from the start of robotic partial nephrectomy to the time decision was made to convert
  • Length of Stay [ Time Frame: 1-7 days ]
    Calculated from day of admission to day of discharge
  • Complication Rates [ Time Frame: Up to 6 months post-surgery ]
    Clavien-Dindo classification and need for/extent of re-intervention
  • Renal Function [ Time Frame: Up to 6 months post-surgery ]
    Creatinine and eGFR measured pre-op, day 1 post-op, 4-7 weeks post-op, 6 months post-op
  • Positive margin rate [ Time Frame: 1-3 weeks post-operatively ]
    Frequency of positive margins as reported in the final pathology report.
  • Margin size [ Time Frame: 1-3 weeks post-operatively ]
    Distance from tumour to surgical margin (mm) as reported in final pathology report.
  • Analgesic Requirements [ Time Frame: Up to 6 months post-operatively ]
    use of epidural, PCA, or oral analgesia
  • Quality of Life: EORTC QLQ-C30 [ Time Frame: Up to 6 months post-operatively ]
    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
  • Surgical Recovery/Flank Bulge [ Time Frame: 6 months from surgical date ]
    Surveyed at 6 months post-operatively
  • Health Economics [ Time Frame: Study duration (2 years) ]
    Estimated overall cost of surgery for each arm (surgical supplies, length of stay, etc.) and cost of post-operative readmissions and ER visits
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of OpeN VErsus RoboTic Partial Nephrectomy
Official Title  ICMJE Comparison of OpeN VErsus RoboTic Partial Nephrectomy Trial - a Feasibility Randomized Controlled Trial
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Renal Masses
Intervention  ICMJE
  • Procedure: Robotic Partial Nephrectomy
    Robotic partial nephrectomy using da Vinci robot.
  • Procedure: Open Partial Nephrectomy
    Standard open partial nephrectomy
Study Arms  ICMJE
  • Active Comparator: Robotic Partial Nephrectomy
    Partial nephrectomy performed using the DaVinci robotic surgical system.
    Intervention: Procedure: Robotic Partial Nephrectomy
  • Active Comparator: Open Partial Nephrectomy
    Partial nephrectomy performed using the open approach.
    Intervention: Procedure: Open Partial Nephrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert Hamilton, MD 416-946-2909 rob.hamilton@uhn.ca
Contact: Kopika Kuhathaas, BSc 416-946-2282 kopika.kuhathaas@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011891
Other Study ID Numbers  ICMJE 18-5885
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP