Renal Masses
Conditions
Keywords
Minimally Invasive Surgery, Robotic Surgery, Partial Nephrectomy, Feasibility
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.
Interventions
PROCEDURERobotic Partial Nephrectomy
Robotic partial nephrectomy using da Vinci robot.
PROCEDUREOpen Partial Nephrectomy
Standard open partial nephrectomy
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Potential | Study duration (2 years) | Rate of accrual \[participants per month\] |
| Suitability of secondary outcome measures | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 1-7 days | Calculated from day of admission to day of discharge |
| Complication Rates | Up to 6 months post-surgery | Clavien-Dindo classification and need for/extent of re-intervention |
| Renal Function | 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 | 1-3 weeks post-operatively | Frequency of positive margins as reported in the final pathology report. |
| Operative Time | Duration of surgery | Operative time in minutes |
| Analgesic Requirements | Up to 6 months post-operatively | use of epidural, PCA, or oral analgesia |
| Quality of Life: EORTC QLQ-C30 | 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 | 6 months from surgical date | Surveyed at 6 months post-operatively |
| Health Economics | 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 |
| Margin size | 1-3 weeks post-operatively | Distance from tumour to surgical margin (mm) as reported in final pathology report. |
| Warm Ischemia Time | Duration of surgery | Measured in minutes from the time of application of first vascular clamp to removal of clamp |
| Blood Loss | 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 | Duration of surgery | Time in minutes from the start of robotic partial nephrectomy to the time decision was made to convert |
Countries
Canada
Outcome results
None listed