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

NCT ID: NCT02933398

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2022-12-31

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.

Conditions

Small Renal Masses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laparoscopic Assisted Partial Nephrectomy

Current standard for partial nephrectomies.

Group Type: ACTIVE_COMPARATOR

Robotic Assisted Nephrectomy

Intervention Type: PROCEDURE

Robotic (Davinci)

Robotic Assisted Partial Nephrectomy

Possible new standard for partial nephrectomies.

Group Type: ACTIVE_COMPARATOR

Laparoscopic Assisted Nephrectomy

Intervention Type: PROCEDURE

Regular Laparoscopic Technique.

Interventions

Robotic Assisted Nephrectomy

Robotic (Davinci)

Intervention Type: PROCEDURE

Laparoscopic Assisted Nephrectomy

Regular Laparoscopic Technique.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Anil Kapoor

MD, FRCSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Joseph's Healthcare Hamilton - McMaster Institute of Urology

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Anil Kapoor, MD, FRCSC

Role: CONTACT

akapoor@mcmaster.ca

905-522-1155 ext. 33218

Camilla Tajzler, BA, CCRA

Role: CONTACT

tajzlec@mcmaster.ca

905-522-1155 ext. 35876

Other Identifiers

RALPLPNNX

Identifier Type: -

Identifier Source: org_study_id