At a glance
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Randomized Controlled Trial to Compare the Operative Outcomes and Complications of Mini-percutaneous Nephrolithotomy (Mini-PCNL) Versus Standard PCNL
In Brief
A clinical study evaluating Standard Percutaneous Nephrolithotomy (sPCNL) and Minimally Invasive Percutaneous Nephrolithotomy (MIP) for Kidney Stone. Completed, enrolled 75 participants across 6 sites in 2 countries.
Detailed Summary
The decision to use standard percutaneous nephrolithotomy (PCNL) versus mini-percutaneous nephrolithotomy (MIP) has been a subject of much debate in the urological community. The investigators propose a randomized controlled trial to compare the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. The results of this study will help guide the decision making regarding these two procedures in the US population and provide further insight into the utility and safety of these procedures. A cost analysis will be performed, and it is hypothesized that the reusable components of the Storz MIP set will result in lower costs of the mini-PCNL procedure compared to standard PCNL.
Study Details
Timeline
Interventions
Endoscopic stone procedure using a laser placed in the kidney through an 30 Fr access sheath following balloon dilation.
Endoscopic stone procedure using a laser placed in the kidney through an 18 Fr access sheath following either balloon dilation or dilation using a single step metal dilator.