Comparison of OpeN VErsus RoboTic Partial Nephrectomy (CONVERT)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Renal Masses
• Intervention / Treatment: Procedure: Robotic Partial Nephrectomy; Procedure: Open 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): July 24, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Partial Nephrectomy; Minimally Invasive Surgery; Robotic Surgery
• Other Study ID Numbers: 18-5885

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No