Comparison of OpeN VErsus RoboTic Partial Nephrectomy (CONVERT)

University Health Network, Toronto

Status: Withdrawn

Conditions: Renal Masses

Treatments: Procedure: Robotic Partial Nephrectomy; Procedure: Open Partial Nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04011891

18-5885

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Robotic Partial Nephrectomy

Active Comparator group

Description:

Partial nephrectomy performed using the DaVinci robotic surgical system.

Treatment:

Procedure: Robotic Partial Nephrectomy

Open Partial Nephrectomy

Active Comparator group

Description:

Partial nephrectomy performed using the open approach.

Treatment:

Procedure: Open Partial Nephrectomy