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

St. Joseph's Healthcare Hamilton

Status and phase: Unknown; Phase 3

Conditions: Small Renal Masses

Treatments: Procedure: Robotic Assisted Nephrectomy; Procedure: Laparoscopic Assisted Nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02933398

RALPLPNNX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Laparoscopic Assisted Partial Nephrectomy

Active Comparator group

Description:

Current standard for partial nephrectomies.

Treatment:

Procedure: Robotic Assisted Nephrectomy

Robotic Assisted Partial Nephrectomy

Active Comparator group

Description:

Possible new standard for partial nephrectomies.

Treatment:

Procedure: Laparoscopic Assisted Nephrectomy