OBJECTIVES
Primary Study Objective:
To evaluate the contemporary indications, clinical efficacy, and safety profile of percutaneous nephrolithotomy (PCNL) for the treatment of renal stones.
Secondary Study Objectives:
To systematically assess intraoperative and postoperative complications of PCNL utilizing the standardized Clavien-Dindo classification system.
To identify and define specific independent risk factors contributing to intraoperative and postoperative complications following PCNL.
To execute a comparative efficacy analysis between miniaturized PCNL techniques and standard PCNL stratified by stone size and complexity.
The captured variables will undergo comprehensive statistical analysis to determine their respective effects on final procedural outcomes, stone-free rates, and perioperative complications. These parameters are categorized as follows:
Patient Preoperative Variables: Age, comorbidities, Body Mass Index (BMI), active anticoagulant/antiplatelet medications, stone configuration, presence of a solitary functioning kidney, and congenital musculoskeletal or anatomical renal abnormalities.
Preoperative Imaging and Diagnostics: Modalities utilized for surgical planning, stone density (Hounsfield units), cumulative stone size/burden, and stone number/location.
Preoperative Urinary Tract Status: Documented frequency of urinary tract infections (UTIs), identification of isolated bacterial strains, and protocols for preoperative antibiotic treatment (including specific drug types and duration).
Intraoperative Variables and Technical Access: Patient positioning (prone vs. supine variations), imaging modalities utilized for renal access puncture, definitive tract size, and the specific method of tract dilatation (balloon, metal telescopic, sequential fascial, or single-step/one-shot dilators).
Instrumentation and Efficacy Metrics: Type and size of the percutaneous access sheath, specific surgical instrumentation utilized (micro, mini, super-mini, ultra-mini, or standard PCNL), energy modalities used for lithotripsy fragmentation, and methods deployed for stone fragment extraction or evacuation.
Exiting Strategies and Postoperative Care: Choice of post-procedural drainage protocols (totally tubeless, tubeless, or standard nephrostomy tube placement, including tube type and size), time to drainage extraction, and total postoperative length of hospital stay.
Morbidity and Follow-Up: Documentation of procedural morbidity, with all adverse events classified according to the Clavien-Dindo system, alongside the subsequent management and treatment of any recorded complications.
DATA COLLECTION AND PROTOCOL MANAGEMENT Patients will be enrolled prospectively and consecutively across participating international sites, targeting a cumulative registry sample of up to 10,000 participants.
The International Alliance of Urolithiasis (IAU) Scientific Committee oversees and provides formal institutional approval for the initiation of data collection at each participating clinical center. Institutions participating in the registry must submit a formal application and cover letter to the IAU Scientific Committee.
Data collection is conducted via a secure, web-based data management system, with each approved clinical center utilizing a unique, personal username and password for system access. Every participating clinical site designates a local study coordinator responsible for ensuring accurate data entry and compliance.
To maintain data integrity, completeness, and quality control across all international centers, the IAU Scientific Committee has established a dedicated Audit Committee for continuous monitoring. Final data analysis and scientific reporting will be guided and coordinated directly by the IAU Scientific Committee.
