Comparison of OpeN VErsus RoboTic Partial Nephrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of OpeN VErsus RoboTic Partial Nephrectomy Trial - a Feasibility Randomized Controlled Trial

Conditions
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Renal Masses

Intervention / Treatment
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* Procedure: Robotic Partial Nephrectomy
* Procedure: Open Partial Nephrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic Partial Nephrectomy<br>Partial nephrectomy performed using the DaVinci robotic surgical system. | Procedure: Robotic Partial Nephrectomy<br>* Robotic partial nephrectomy using da Vinci robot.<br>|
| Active Comparator: Open Partial Nephrectomy<br>Partial nephrectomy performed using the open approach. | Procedure: Open Partial Nephrectomy<br>* Standard open partial nephrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Potential | Rate of accrual [participants per month] | 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. | 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. | 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. | Study duration (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Operative time in minutes | Duration of surgery | 
| Warm Ischemia Time | Measured in minutes from the time of application of first vascular clamp to removal of clamp | Duration of surgery | 
| Blood Loss | Estimated blood loss (mL), transfusion rates, use of hemostatic agents (which agents and how many used) | 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 | Duration of surgery | 
| Length of Stay | Calculated from day of admission to day of discharge | 1-7 days | 
| Complication Rates | Clavien-Dindo classification and need for/extent of re-intervention | 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 | Up to 6 months post-surgery | 
| Positive margin rate | Frequency of positive margins as reported in the final pathology report. | 1-3 weeks post-operatively | 
| Margin size | Distance from tumour to surgical margin (mm) as reported in final pathology report. | 1-3 weeks post-operatively | 
| Analgesic Requirements | use of epidural, PCA, or oral analgesia | 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 | Up to 6 months post-operatively | 
| Surgical Recovery/Flank Bulge | Surveyed at 6 months post-operatively | 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 | Study duration (2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Surgery, Robotic Surgery, Partial Nephrectomy, Feasibility