Comparison of OpeN VErsus RoboTic Partial Nephrectomy (CONVERT)

  • STATUS
    Recruiting
  • End date
    Nov 5, 2023
  • participants needed
    30
  • sponsor
    University Health Network, Toronto
Updated on 5 May 2022

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.

Details
Condition Renal Masses
Treatment Open partial nephrectomy, Robotic Partial Nephrectomy
Clinical Study IdentifierNCT04011891
SponsorUniversity Health Network, Toronto
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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