A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.

Conditions
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Small Renal Masses

Intervention / Treatment
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* Procedure: Robotic Assisted Nephrectomy
* Procedure: Laparoscopic Assisted Nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 18 years of age and capable of giving informed consent Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN Patients with SRMs (tumor(s) ≤ 4 cm) Exclusion Criteria: Large tumors > 4.0cm Unable to have a general anesthetic Unable to comply with post-operative follow-up protocol Uncorrectable bleeding diathesis Tumors unsuitable for LPN/RALPN technique Evidence of metastatic disease Prior surgery on the affected kidney Ectopic or malrotated kidney Mental health condition that precludes informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Assisted Partial Nephrectomy<br>Current standard for partial nephrectomies. | Procedure: Robotic Assisted Nephrectomy<br>* Robotic (Davinci)<br>|
| Active Comparator: Robotic Assisted Partial Nephrectomy<br>Possible new standard for partial nephrectomies. | Procedure: Laparoscopic Assisted Nephrectomy<br>* Regular Laparoscopic Technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Duration of the Surgical Procedure (Nephrectomy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR | It will be measured preoperatively, postoperatively and at each of the follow-up visit. | Up to 24 months post operatively. | 
| Estimated blood loss | Will be measured intraoperatively from the amount of blood (ml) in the suction container. | 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. | 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. | Duration of the Surgical Procedure | 
| Postoperative pain |  | 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. | 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). | 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. | Up to 1 year |