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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Al-Azhar University • ClinicalTrials.gov ID: NCT07753733

Registry updated: 2026-09-01
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Description

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.

Interventions

  • Flexible Nephroscopy-Assisted Single-Tract PCNL (Procedure)
    Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
  • Conventional Multi-Tract PCNL (Procedure)
    Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.

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. \-

Conditions

Percutaneous Nephrolithotomy

Locations

  • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University — Cairo, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record