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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Robotic partial nephrectomy using da Vinci robot.
Standard open partial nephrectomy
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruitment Potential
Rate of accrual \[participants per month\]
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Study duration (2 years)
Operative Time
Operative time in minutes
Time frame: Duration of surgery
Warm Ischemia Time
Measured in minutes from the time of application of first vascular clamp to removal of clamp
Time frame: Duration of surgery
Blood Loss
Estimated blood loss (mL), transfusion rates, use of hemostatic agents (which agents and how many used)
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Time frame: 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
Time frame: Duration of surgery
Length of Stay
Calculated from day of admission to day of discharge
Time frame: 1-7 days
Complication Rates
Clavien-Dindo classification and need for/extent of re-intervention
Time frame: 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
Time frame: Up to 6 months post-surgery
Positive margin rate
Frequency of positive margins as reported in the final pathology report.
Time frame: 1-3 weeks post-operatively
Margin size
Distance from tumour to surgical margin (mm) as reported in final pathology report.
Time frame: 1-3 weeks post-operatively
Analgesic Requirements
use of epidural, PCA, or oral analgesia
Time frame: 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
Time frame: Up to 6 months post-operatively
Surgical Recovery/Flank Bulge
Surveyed at 6 months post-operatively
Time frame: 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
Time frame: Study duration (2 years)