Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones
NCT07753733 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 470
Last updated 2026-08-12
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.
Conditions
- Percutaneous Nephrolithotomy
Interventions
- PROCEDURE
-
Flexible Nephroscopy-Assisted Single-Tract PCNL
Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
- PROCEDURE
-
Conventional Multi-Tract PCNL
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
Sponsors & Collaborators
-
Al-Azhar University
lead OTHER
Principal Investigators
-
Abul-fotouh Ahmed · Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-10
- Primary Completion
- 2028-06-30
- Completion
- 2028-08-30
Countries
- Egypt
Study Locations
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