Comparison of OpeN VErsus RoboTic Partial Nephrectomy

Renal Masses Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04011891
• Other study ID #: 18-5885
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 24, 2023

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Masses

Intervention

Procedure:
• Robotic Partial Nephrectomy
Robotic partial nephrectomy using da Vinci robot.
• Open Partial Nephrectomy
Standard open partial nephrectomy

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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