Percutaneous Nephrolithotomy
Conditions
Keywords
Renal stones, Flexible Nephroscopy, Multi-tract
Brief 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.
Detailed description
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.
Interventions
PROCEDUREFlexible 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.
PROCEDUREConventional Multi-Tract PCNL
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate at 3 months. | 3 months after surgery. | Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative | Time from skin incision or anesthesia induction to completion of the procedure. |
| Fluoroscopy time | Intraoperative | Total duration of fluoroscopy exposure during the procedure. |
| Number of tracts | Intraoperative | Total number of percutaneous renal access tracts used to complete stone clearance. |
| Hemoglobin drop | From baseline to postoperative day 1. | Difference between preoperative hemoglobin and postoperative day 1 hemoglobin. |
| Transfusion rate | Perioperative/Periprocedural | Proportion of patients requiring blood transfusion after surgery. |
| Duration of Postoperative Hospitalization | From the date of PCNL surgery until hospital discharge. | 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. |
| Complication rate | Up to 3 months | Postoperative complications classified according to the Clavien-Dindo grading system. |
Countries
Egypt
Contacts
CONTACTAbul-fotouh Ahmed
PRINCIPAL_INVESTIGATORAbul-fotouh Ahmed
Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Outcome results
None listed