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.
This prospective randomized non-inferiority trial will enroll adults aged 18-70 years with complex unilateral renal stones anticipated to require multiple accesses. Participants will be randomized in a 1:1 ratio to either flexible nephroscopy-assisted single-tract PCNL or conventional multi-tract PCNL. The study aims to determine whether the single-tract approach is not inferior to the multi-tract approach with respect to stone-free rate at 3 months, while potentially reducing perioperative morbidity, including bleeding, transfusion, operative time, and length of hospital stay. Secondary analyses will evaluate complication profiles using Clavien-Dindo classification, need for auxiliary procedures, cost-effectiveness, and the predictive value of Guy's Stone Score and S.T.O.N.E. score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
470
Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo, Egypt
RECRUITINGStone-free rate at 3 months.
Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.
Time frame: 3 months after surgery.
Operative time
Time from skin incision or anesthesia induction to completion of the procedure.
Time frame: Intraoperative
Fluoroscopy time
Total duration of fluoroscopy exposure during the procedure.
Time frame: Intraoperative
Number of tracts
Total number of percutaneous renal access tracts used to complete stone clearance.
Time frame: Intraoperative
Hemoglobin drop
Difference between preoperative hemoglobin and postoperative day 1 hemoglobin.
Time frame: From baseline to postoperative day 1.
Transfusion rate
Proportion of patients requiring blood transfusion after surgery.
Time frame: Perioperative/Periprocedural
Duration of Postoperative Hospitalization
Duration of postoperative hospitalization will be calculated as the number of days from the date of PCNL surgery until the date of hospital discharge. The date of surgery will be counted as Day 0. The reason for prolonged hospitalization, when applicable, will be documented.
Time frame: From the date of PCNL surgery until hospital discharge.
Complication rate
Postoperative complications classified according to the Clavien-Dindo grading system.
Time frame: Up to 3 months
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