RecruitingNCT07622238

IAU Percutaneous Nephrolithotripsy Study

International Alliance of Urolithiasis Percutaneous Nephrolithotripsy Study


Sponsor

Foundation Endourology

Enrollment

4,000 participants

Start Date

Aug 15, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Percutaneous nephrolithotomi (PCNL) for people with kidney calculi and urolithiasis. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPercutaneous nephrolithotomi (PCNL)

Patients included in this observational study undergo Percutaneous Nephrolithotomy (PCNL) for the treatment of renal calculi according to the established protocols of each participating center. The surgical procedure involves creating a percutaneous tract to the renal collecting system under ultrasound, fluoroscopic, or combined guidance. The study observes a wide spectrum of contemporary techniques, including standard-tract PCNL and miniaturized versions (Mini-PCNL), performed in either prone or supine positions. Specific procedural data are recorded, including the method of tract dilation (balloon, telescopic, or single-step), the type of lithotripsy energy used (laser, ultrasonic, or pneumatic), and postoperative drainage strategies (standard nephrostomy, tubeless, or stent-only). As an observational study, the choice of specific technique and equipment is determined by the treating surgeon based on clinical indications and institutional standards.


Locations(4)

Foundation Endourology

Sofia, Sofia-Grad, Bulgaria

Foundation Endourology

Sofia, Sofia-Grad, Bulgaria

Foundation Endourology

Sofia, Sofia-Grad, Bulgaria

Military Medical Academy, Department of Urology and Nephrology

Sofia, Sofia-Grad, Bulgaria

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NCT07622238


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