Study of Percutaneous Nephrolithotomy Techniques for Kidney and Ureteral Stones Evaluating Safety, Effectiveness, and Complications Across Different Methods

What this Trial Is About

Researchers are investigating the current use, effectiveness, and safety of percutaneous nephrolithotomy PCNL for treating kidney stones. This observational study, led by the International Alliance of Urolithiasis IAU, aims to evaluate different PCNL techniques, including miniaturized versions, and compare them to standard methods. The study also seeks to identify risk factors for complications during and after surgery, using a standardized classification system to assess outcomes. Participants undergo PCNL procedures according to their clinical centers protocols, which use various imaging methods like ultrasound or fluoroscopy to access the kidney. Techniques include standard and miniaturized PCNL performed in different patient positions, with details recorded on tract dilation methods, lithotripsy energy types, and drainage strategies after surgery. The study collects data over 12 to 18 months at multiple centers worldwide, with oversight by the IAU Scientific Committee and an audit team for quality control. During the study, participants clinical data are entered securely by local coordinators at each site. Researchers collect detailed preoperative, intraoperative, and postoperative information, including imaging results, stone characteristics, surgical details, complication rates, hospital stay duration, and kidney function changes. The primary outcome is the stone-free rate one month after surgery, with secondary measures including complication rates within 30 days, hemoglobin changes, operative time, and length of hospital stay. The study plans to include up to 10,000 patients to better understand PCNL outcomes and safety.

IAU Percutaneous Nephrolithotripsy Study