Clinical trial NCT02933398: A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses
Official title: A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Small Renal Masses
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients at least 18 years of age and capable of giving informed consent
2. Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
3. Patients with SRMs (tumor(s) ≤ 4 cm)

Exclusion Criteria:

1. Large tumors \> 4.0cm
2. Unable to have a general anesthetic
3. Unable to comply with post-operative follow-up protocol
4. Uncorrectable bleeding diathesis
5. Tumors unsuitable for LPN/RALPN technique
6. Evidence of metastatic disease
7. Prior surgery on the affected kidney
8. Ectopic or malrotated kidney
9. Mental health condition that precludes informed consent

Primary outcomes:
measure: Warm ischemia time
timeFrame: Duration of the Surgical Procedure (Nephrectomy)
Secondary outcomes:
measure: eGFR
timeFrame: Up to 24 months post operatively.
measure: Estimated blood loss
timeFrame: Duration of the Surgical Procedure (Nephrectomy)
measure: Complication rates as per Clavien-Dindo classification
timeFrame: Up to 24 months post-operatively.
measure: Conversion rate to radical nephrectomy or OPN due to technical difficulty.
timeFrame: Duration of the Surgical Procedure
measure: Postoperative pain
timeFrame: Minutes to hours after nephrectomy up to 3 months post-operatively.
measure: Length of hospital stay
timeFrame: 3-7 Days
measure: Positive surgical margin rate
timeFrame: 14 days
measure: Costs of treatment
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
state: Ontario
Study officials:
References: