Clinical trial NCT04011891: Comparison of OpeN VErsus RoboTic Partial Nephrectomy
Official title: Comparison of OpeN VErsus RoboTic Partial Nephrectomy Trial - a Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Masses
Keywords: Minimally Invasive Surgery
Robotic Surgery
Partial Nephrectomy
Feasibility
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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
* Inability to read, understand, and complete the questionnaires written in English

Primary outcomes:
measure: Recruitment Potential
timeFrame: Study duration (2 years)
measure: Suitability of secondary outcome measures
timeFrame: Study duration (2 years)
measure: Resource Utilization - Operating Room/Robotic Studio Time Availability
timeFrame: Study duration (2 years)
measure: Resource Utilization - Cost of Study Participation
timeFrame: Study duration (2 years)
Secondary outcomes:
measure: Operative Time
timeFrame: Duration of surgery
measure: Warm Ischemia Time
timeFrame: Duration of surgery
measure: Blood Loss
timeFrame: Duration of surgery
measure: Conversion rate to radical nephrectomy or open partial nephrectomy
timeFrame: Duration of surgery
measure: Length of Stay
timeFrame: 1-7 days
measure: Complication Rates
timeFrame: Up to 6 months post-surgery
measure: Renal Function
timeFrame: Up to 6 months post-surgery
measure: Positive margin rate
timeFrame: 1-3 weeks post-operatively
measure: Margin size
timeFrame: 1-3 weeks post-operatively
measure: Analgesic Requirements
timeFrame: Up to 6 months post-operatively
measure: Quality of Life: EORTC QLQ-C30
timeFrame: Up to 6 months post-operatively
measure: Surgical Recovery/Flank Bulge
timeFrame: 6 months from surgical date
measure: Health Economics
timeFrame: Study duration (2 years)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: