Comparison of OpeN VErsus RoboTic Partial Nephrectomy

NCT04011891 | Withdrawn

• 1 other identifier: 18-5885
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Masses

Keywords

Minimally Invasive Surgery; Robotic Surgery; Partial Nephrectomy; Feasibility

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Operative Time

  Duration of surgery

• Warm Ischemia Time

  Duration of surgery

• Blood Loss

  Duration of surgery

• Conversion rate to radical nephrectomy or open partial nephrectomy

  Duration of surgery

• Length of Stay

  1-7 days

Study Arms (2)

Robotic Partial Nephrectomy

ACTIVE COMPARATOR

Partial nephrectomy performed using the DaVinci robotic surgical system.

Procedure: Robotic Partial Nephrectomy

Open Partial Nephrectomy

ACTIVE COMPARATOR

Partial nephrectomy performed using the open approach.

Procedure: Open Partial Nephrectomy

Interventions

Robotic Partial Nephrectomy PROCEDURE

Robotic partial nephrectomy using da Vinci robot.

Robotic Partial Nephrectomy

Open Partial Nephrectomy PROCEDURE

Standard open partial nephrectomy

Open Partial Nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: July 9, 2019
• Study Start: November 1, 2019
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CA (1)