Comparison of OpeN VErsus RoboTic Partial Nephrectomy Trial - a Feasibility Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Masses
- Sponsor
- University Health Network, Toronto
- Locations
- 1
- Primary Endpoint
- Suitability of secondary outcome measures
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 - 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.
Recruitment Potential
Time Frame: Study duration (2 years)
Rate of accrual \[participants per month\]
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.
Secondary Outcomes
- Conversion rate to radical nephrectomy or open partial nephrectomy(Duration of surgery)
- Complication Rates(Up to 6 months post-surgery)
- Positive margin rate(1-3 weeks post-operatively)
- Surgical Recovery/Flank Bulge(6 months from surgical date)
- Operative Time(Duration of surgery)
- Warm Ischemia Time(Duration of surgery)
- Health Economics(Study duration (2 years))
- Blood Loss(Duration of surgery)
- Length of Stay(1-7 days)
- Renal Function(Up to 6 months post-surgery)
- Margin size(1-3 weeks post-operatively)
- Analgesic Requirements(Up to 6 months post-operatively)
- Quality of Life: EORTC QLQ-C30(Up to 6 months post-operatively)