Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones

Sex: All

Ages: 18 Years – 70 Years

Healthy volunteers: No

Phase: NA

Enrollment: 470

Sponsor: Al-Azhar University

Location: Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University Cairo

Summary

This randomized, parallel-group, non-inferiority trial will compare flexible nephroscopy-assisted single-tract percutaneous nephrolithotomy with conventional multi-tract percutaneous nephrolithotomy in patients with complex unilateral renal stones. The primary outcome is stone-free rate at 3 months, and secondary outcomes include operative time, fluoroscopy time, hemoglobin drop, transfusion rate, hospital stay, complications, need for auxiliary procedures, and cost-effectiveness.

Eligibility Criteria

Inclusion Criteria: * Age 18-70 years. Unilateral complex renal stones defined by one or more of the following: Guy's Stone Score III-IV, S.T.O.N.E. score ≥9, staghorn or partial staghorn calculus, or stones involving at least 3 calyces on NCCT. Preoperative expectation of multiple accesses by the surgeon. Written informed consent. Exclusion Criteria: Solitary kidney. Uncorrected coagulopathy. Active urinary tract infection. ASA grade IV or higher. Pregnancy. Previous ipsilateral PCNL or open renal surgery. Stones less than 2 cm or simple calyceal stones. Refusal or inability to comply with follow-up. \-

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07753733). StuddyBuddy aggregates publicly available trial information.