A Prospective Trial of Feasibility and Efficacy of Simultaneous Bilateral Percutaneous Nephrolithotomy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Stone Free Rates Measured using Chi-Square analysis.
Study Overview
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.
Detailed Description
Purpose:
The aim of this research is to determine an 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.
Hypothesis and Justification The gold standard for surgical management of large kidney stones is percutaneous nephrolithotomy (PCNL). A large renal stone burden has been defined as >20mm. In addition, PCNL has improved stone-free rates for lower pole calculi >10mm compared to alternative treatments. Guidelines encourage removal of staghorn calculi for surgical candidates (Assimos et al., 2016). Patients with bilateral large stone burdens have been managed with one of two general options: (i) a single procedure in which both kidneys are operated upon or (ii) two separate procedures in which only one kidney is addressed per procedure. However, there are no prospectively performed peer-reviewed studies directly comparing the two practices. The investigators seek to determine whether there is a significant difference in patient outcomes based on the surgical regimen chosen.
The investigators hypothesize that in comparison to unilateral PCNL (U-PCNL), simultaneous bilateral PCNL (SB-PCNL) under one anesthetic results in comparable
- stone free rates
- re-intervention rates for residual stones and
- perioperative complication rates
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All subjects with a clinical diagnosis of struvite calculi will potentially be included. Specific inclusion criteria include the following:
- •Age >18 years
- •Any patient with bilateral stone burden eligible and appropriate for PCNL procedure
- •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:
- •Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
- •Patients who are unable to provide informed consent.
- •Patients who are planned for alternative procedures (ureteroscopy, extracorporeal shock wave lithotripsy)
- •Anyone who is unable to give their informed consent
- •Anyone under the age of 19
- •Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study
Outcomes
Primary Outcomes
Stone Free Rates Measured using Chi-Square analysis.
Time Frame: 3 months.
Rate of clearance of kidney stones following the procedure.
Number of Participants with Repeat procedures
Time Frame: 3 months.
Number of Participants requiring repeat surgical procedures for residual stones following initial treatment.
Secondary Outcomes
- Patient Quality of Life(3 months.)
- Length of hospital stay(3 months.)
- Number of Participants with Complications(3 months.)
Investigators
Ben Chew, MD
Associate Professor
University of British Columbia