A Phase 3 interventional study of Robotic Assisted Nephrectomy and Laparoscopic Assisted Nephrectomy in Small Renal Masses, sponsored by St. Joseph's Healthcare Hamilton. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by St. Joseph's Healthcare Hamilton · Phase 3, Interventional, and Treatment
A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (\<4 cm) amenable to resection using either RALPN or LPN.
Small renal masses (SRM) \<4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.
The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.
St. Joseph's Healthcare Hamilton is the lead sponsor of 137 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Current standard for partial nephrectomies.
Procedure: Robotic Assisted Nephrectomy
Possible new standard for partial nephrectomies.
Procedure: Laparoscopic Assisted Nephrectomy
Robotic (Davinci)
Regular Laparoscopic Technique.
Warm ischemia time
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
Time frame: Duration of the Surgical Procedure (Nephrectomy)
eGFR
It will be measured preoperatively, postoperatively and at each of the follow-up visit.
Time frame: Up to 24 months post operatively.
Estimated blood loss
Will be measured intraoperatively from the amount of blood (ml) in the suction container.
Time frame: Duration of the Surgical Procedure (Nephrectomy)
Complication rates as per Clavien-Dindo classification
It will be recorded for the intra-operative, post-operative and follow-up period.
Time frame: Up to 24 months post-operatively.
Conversion rate to radical nephrectomy or OPN due to technical difficulty.
From the start of the partial nephrectomy in minutes to the time it was decided to convert to a radical nephrectomy.
Time frame: Duration of the Surgical Procedure
Postoperative pain
Time frame: Minutes to hours after nephrectomy up to 3 months post-operatively.
Length of hospital stay
Calculated from day of admission to day of discharge from hospital.
Time frame: 3-7 Days
Positive surgical margin rate
Will be based on the final pathology results which are usually ready in 1-2 weeks post surgery. Distance to surgical margin will be looked at (mm to cm).
Time frame: 14 days
Costs of treatment
Clinical data and resource use for both treatments will be collected and unit cost estimates will be based on the St. Joseph Healthcare case-costing system. The cost will be conducted from the perspective of Ontario Ministry of Health and Long-term Care. The cost of hospital stay will be calculated along with any hospital stay/procedure associated with a post-op complication.
Time frame: Up to 1 year
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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St. Joseph's Healthcare Hamilton