NCT04011891

Comparison of OpeN VErsus RoboTic Partial Nephrectomy

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Masses

Interventions

Type	Name	Description
PROCEDURE	Robotic Partial Nephrectomy	Robotic partial nephrectomy using da Vinci robot.
PROCEDURE	Open Partial Nephrectomy	Standard open partial nephrectomy

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-07-24
• Completion: 2023-07-24
• First posted: 2019-07-09
• Last updated: 2023-07-27

Locations

1 site across 1 country: Canada