Recruiting

PCNL

Sponsor:

University of British Columbia

Code:

NCT03924362

Conditions

Nephrolithiasis of Both Kidneys

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PCNL

Study Details

Brief summary:

The purpose of this study is to determine the effective regimen for definitive surgical therapy of bilateral kidney stones. It is unknown whether patients who undergo simultaneous bilateral percutaneous nephrolithotomy (PCNL) experience improved post-operative outcomes compared to patients who have staged unilateral procedures.

Conditions

Nephrolithiasis of Both Kidneys

Study ID

NCT03924362

Start date

Sep 30, 2019

Status verified date

May, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

All subjects with a clinical diagnosis of struvite calculi will potentially be included. Specific inclusion criteria include the following:

1. Age >18 years
2. Any patient with bilateral stone burden eligible and appropriate for PCNL procedure
3. Medically fit for definitive surgical management of stone.

Exclusion Criteria:

Patients with any of the following characteristics will not be eligible for the present study:

1. Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
2. Patients who are unable to provide informed consent.
3. Patients who are planned for alternative procedures (ureteroscopy, extracorporeal shock wave lithotripsy)
4. Anyone who is unable to give their informed consent
5. Anyone under the age of 19
6. Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

Study Design

Enrollment

92 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Simultaneous Bilateral PCNL

Patients undergo simultaneous bilateral PCNL.

active comparator: Unilateral PCNL

Patients undergoing unilateral staged PCNL.

Interventions

PCNL

Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.

Primary outcome measure

  • Stone Free Rates Measured using Chi-Square analysis. [ Time Frame: 3 months. ]
  • Number of Participants with Repeat procedures [ Time Frame: 3 months. ]

Central Contacts and Locations

Central contacts

Victor Wong

604-875-4111kfvwong@alumni.ubc.ca

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Victor Wong, BSc

6048754111victor.kf.wong@ubc.ca

Principal Investigator:

Ben H Chew, MD

More Information

Sponsor

University of British Columbia

Last update posted

May 17, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-05-17.