A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Warm ischemia time
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Warm ischemia time
Time Frame: Duration of the Surgical Procedure (Nephrectomy)
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
Secondary Outcomes
- Complication rates as per Clavien-Dindo classification(Up to 24 months post-operatively.)
- Estimated blood loss(Duration of the Surgical Procedure (Nephrectomy))
- Positive surgical margin rate(14 days)
- Costs of treatment(Up to 1 year)
- Conversion rate to radical nephrectomy or OPN due to technical difficulty.(Duration of the Surgical Procedure)
- Postoperative pain(Minutes to hours after nephrectomy up to 3 months post-operatively.)
- eGFR(Up to 24 months post operatively.)
- Length of hospital stay(3-7 Days)
Investigators
Anil Kapoor
MD, FRCSC
McMaster University