Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-11-01
2023-07-24
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Robotic Partial Nephrectomy
Partial nephrectomy performed using the DaVinci robotic surgical system.
Robotic Partial Nephrectomy
Robotic partial nephrectomy using da Vinci robot.
Open Partial Nephrectomy
Partial nephrectomy performed using the open approach.
Open Partial Nephrectomy
Standard open partial nephrectomy
Interventions
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Robotic Partial Nephrectomy
Robotic partial nephrectomy using da Vinci robot.
Open Partial Nephrectomy
Standard open partial nephrectomy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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18-5885
Identifier Type: -
Identifier Source: org_study_id
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