Comparison of OpeN VErsus RoboTic Partial Nephrectomy

Not Applicable

Withdrawn

• Conditions: Renal Masses
• Interventions: Procedure: Robotic Partial Nephrectomy; Procedure: Open Partial Nephrectomy

• Registration Number: NCT04011891
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-09
• Study Start: 2019-11-01
• Status Verified: 2023-07
• Primary Completion: 2023-07-24
• Study Completion: 2023-07-24
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Partial Nephrectomy	Robotic Partial Nephrectomy	Partial nephrectomy performed using the DaVinci robotic surgical system.
Open Partial Nephrectomy	Open Partial Nephrectomy	Partial nephrectomy performed using the open approach.

Primary Outcome Measures

Name	Time	Method
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 - 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.
Recruitment Potential	Study duration (2 years)	Rate of accrual \[participants per month\]
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.

Secondary Outcome Measures

Name	Time	Method
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
Complication Rates	Up to 6 months post-surgery	Clavien-Dindo classification and need for/extent of re-intervention
Positive margin rate	1-3 weeks post-operatively	Frequency of positive margins as reported in the final pathology report.
Surgical Recovery/Flank Bulge	6 months from surgical date	Surveyed at 6 months post-operatively
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)
Length of Stay	1-7 days	Calculated from day of admission to day of discharge
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
Margin size	1-3 weeks post-operatively	Distance from tumour to surgical margin (mm) as reported in final pathology report.
Analgesic Requirements	Up to 6 months post-operatively	use of epidural, PCA, or oral analgesia
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
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
Operative Time	Duration of surgery	Operative time in minutes

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada