Comparison Between Supine Mini-PCNL and Flexible Ureteroscopy (FURS) for Dense Lower Calyceal Stones (1-2 cm) in School-Age Pediatric Patients

Ain Shams University180 enrolled

Overview

This randomized controlled clinical study compared supine mini percutaneous nephrolithotomy versus flexible ureteroscopy for the management of dense lower calyceal renal stones measuring 1-2 centimeters (≤20 millimeters) with stone density greater than 1000 Hounsfield units in school-age pediatric patients aged 6-12 years. Participants were randomized to undergo either supine mini percutaneous nephrolithotomy with laser lithotripsy or flexible ureteroscopy with laser lithotripsy. The study assessed stone-free rate on non-contrast computed tomography of the urinary tract at 1 month postoperatively, along with operative time, fluoroscopy time, intraoperative and postoperative complications, and length of hospital stay. The trial has ended.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Nephrolithiasis Kidney Calculi Urolithiasis

Interventions

Supine Mini Percutaneous NephrolithotomyPROCEDURE

Percutaneous renal access and tract dilation to mini size in the supine position, followed by endoscopic stone fragmentation using laser lithotripsy, with ureteral stent placement and nephrostomy tube placement per protocol.

Flexible UreteroscopyPROCEDURE

Retrograde endoscopic access to the kidney using a flexible ureteroscope with laser lithotripsy for stone fragmentation, followed by ureteral stent placement per protocol.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 6 to 12 years * Single lower calyceal renal stone measuring 1-2 centimeters (≤20 millimeters) with stone density greater than 1000 Hounsfield units * No previous urological surgery that could distort the pelvicalyceal system Exclusion Criteria: * Additional ureteral stones and/or congenital renal anomalies (for example, horseshoe kidney or pelviureteric junction obstruction) * Multiple renal stones * Untreated urinary tract infection (temporarily excluded until treated)

Outcomes

Primary Outcomes

Stone-Free Rate

Proportion of participants who were stone-free on non-contrast computed tomography of the urinary tract at 1 month after the procedure. Clinically insignificant residual fragments were defined as asymptomatic residual stones smaller than 2 millimeters.

Time frame: 1 month postoperatively

Secondary Outcomes

Operative Time

Total operative time for the assigned procedure (in minutes).

Time frame: Intraoperative

Fluoroscopy Time

Total fluoroscopy time used during the procedure (in seconds or minutes, per recorded operating room log).

Time frame: Intraoperative

Length of Hospital Stay

Duration of postoperative hospital stay (in days) following the procedure.

Time frame: From end of procedure (day of surgery) until hospital discharge, assessed up to 30 days.

Intraoperative and Postoperative Complications

Frequency and type of complications occurring intraoperatively and during follow-up after the procedure.

Time frame: Up to 3 months postoperatively