Kidney Calculi, Nephrolithiasis, Urolithiasis
Conditions
Keywords
pediatric, children, school-age, lower calyx, lower pole, renal stone, kidney stone, flexible ureteroscopy, high-density stone, mini percutaneous nephrolithotomy, laser lithotripsy
Brief summary
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.
Interventions
PROCEDURESupine Mini Percutaneous Nephrolithotomy
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.
PROCEDUREFlexible Ureteroscopy
Retrograde endoscopic access to the kidney using a flexible ureteroscope with laser lithotripsy for stone fragmentation, followed by ureteral stent placement per protocol.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study; participants and treating clinicians were aware of the assigned procedure. Outcome assessment was based on postoperative imaging and clinical follow-up.
Intervention model description
Participants were randomly assigned to one of two parallel groups to undergo either supine mini percutaneous nephrolithotomy with laser lithotripsy or flexible ureteroscopy with laser lithotripsy for management of dense lower calyceal renal stones.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate | 1 month postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intraoperative | Total operative time for the assigned procedure (in minutes). |
| Fluoroscopy Time | Intraoperative | Total fluoroscopy time used during the procedure (in seconds or minutes, per recorded operating room log). |
| Length of Hospital Stay | From end of procedure (day of surgery) until hospital discharge, assessed up to 30 days. | Duration of postoperative hospital stay (in days) following the procedure. |
| Intraoperative and Postoperative Complications | Up to 3 months postoperatively | Frequency and type of complications occurring intraoperatively and during follow-up after the procedure. |
Countries
Egypt
Outcome results
None listed