An interventional study of PCNL in Nephrolithiasis of Both Kidneys, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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
Objectives
The objectives are:
Research Design This study will be a prospective, non-randomized, multi-centre, non-blinded trial. Participants will be accrued through the Vancouver General Hospital Stone Center who have been referred for bilateral stones or have been seen in consultation for bilateral stones at the Department of Urologic Sciences and are scheduled for a percutaneous nephrolithotomy (PCNL). Consent forms and Letters of Introduction outlining the study will be given to patients by a research coordinator once the decision is made to book surgery. Patients will have at least 24 hours to decide to participate. Patients will receive surgical management for their stones in the form of PCNL. A computed tomography (CT) scan of the kidneys will be performed post-operatively by week 6 to determine if any residual stone fragments are present. Patients will be seen in follow up at 3 months in clinic after undergoing a follow up CT KUB, renal ultrasound, or KUB as necessary to evaluate stone clearance.
460 studies on the registry are indexed under Nephrolithiasis; 108 are open to participants now.
This study's planned enrollment of 92 is close to the median of 92 across 361 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
All subjects with a clinical diagnosis of struvite calculi will potentially be included. Specific inclusion criteria include the following:
Exclusion Criteria:
Patients with any of the following characteristics will not be eligible for the present study:
Patients undergo simultaneous bilateral PCNL.
Procedure: PCNL
Patients undergoing unilateral staged PCNL.
Procedure: PCNL
Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.
Stone Free Rates Measured using Chi-Square analysis.
Rate of clearance of kidney stones following the procedure.
Time frame: 3 months.
Number of Participants with Repeat procedures
Number of Participants requiring repeat surgical procedures for residual stones following initial treatment.
Time frame: 3 months.
Length of hospital stay
Hospital stay for simultaneous bilateral versus staged PCNL.
Time frame: 3 months.
Number of Participants with Complications
Number of participants with perioperative complication and rates for each procedure.
Time frame: 3 months.
Patient Quality of Life
Quality of life assessment comparing the two different procedures will be conducted with the Wisconsin Stone Quality of Life questionnaire (WISQOL). WISQOL is a disease-specific, health-related quality of life measure designed for patients who form kidney stones. This questionnaire has 4 different domains: social-domain 1, emotional-domain 2, stone related-domain 3 and vitality-domain 4. In the questionnaire, patients are to answer between 1 (Very true) to 5 (Not true at all). 1 is the worst outcome, and 5 is the best outcome.
Time frame: 3 months.
Plan to share: No — The University of British Columbia is the main site of the study, therefore all data will be transferred from the subsites to the University of British Columbia, and no transfer of data to the subsites. Any data transfer will be de-identified.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of British Columbia