About this trial
During the past 10-15 years, important advancements have been witnessed in percutaneous nephrolithotomy (PCNL) techniques and instrumentation. The development of miniaturized PCNL techniques and modern laser technologies has contributed to lower complication rates, alongside changes in exiting strategies and postoperative drainage protocols. Ultrasound is increasingly utilized to create percutaneous access, and many medical centers have transitioned to the supine position for PCNL or perform Endoscopic Combined Intrarenal Surgery (ECIRS). All these developments have helped to individualize treatment strategies and to improve clinical outcomes for patients. However, there remains an ongoing discussion regarding the optimal indications and limitations of the different miniaturized PCNL techniques compared to standard PCNL and retrograde intrarenal surgery (RIRS).
This prospective observational study is organized under the auspices of the International Alliance of Urolithiasis (IAU) and focuses on the contemporary indications, surgical techniques, instrumentation, exiting strategies, efficacy, and risk factors for intraoperative and postoperative complications of PCNL. Participating investigators will collect data on the PCNL procedures performed in their respective clinical centers prospectively for a period of 12-18 months. The study will be initiated in each clinical center following formal approval from the IAU Scientific Committee, which will also announce the conclusion of the study.
Eligibility criteria
Qualifiers
Patient age 18 years or older at the time of enrollment.
Diagnosed with single or multiple renal calculi (including complex and staghorn calculi) or proximal ureteral stones.
Scheduled to undergo any primary or secondary percutaneous surgical stone intervention, including standard percutaneous nephrolithotomy (PCNL) or any of its miniaturized variations (Mini-PCNL, Ultra-mini PCNL, Super-mini PCNL, or Micro-PCNL).
Voluntarily provided written informed consent for participation and data utilization.
Disqualifiers
Patient age under 18 years.
Patients scheduled to undergo alternative primary treatment modalities for the targeted stone burden as a standalone procedure (e.g., retrograde intrarenal surgery [RIRS] or shockwave lithotripsy [SWL]).
Presence of an active, untreated urinary tract infection (UTI) or clinical urosepsis at the time of the scheduled surgical procedure.
Uncorrected severe coagulopathy or uncorrectable bleeding diathesis.
Trial design
Treatments tested in this trial
- Percutaneous nephrolithotomi (PCNL)
Treatment groups
Sponsors and collaborators
Foundation Endourology
Lead sponsor
The International Alliance of Urolithiasis
Collaborator