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Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy

Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy In Management Of Pediatric Renal Stone Less Than 2 Cm: A Prospective Randomized Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07700251
Enrollment
60
Registered
2026-07-14
Start date
2025-08-01
Completion date
2026-08-10
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Renal Stone

Brief summary

Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%. This increasing incidence poses a growing public health concern. The primary objective in managing pediatric renal stones is complete stone clearance while minimizing complications and improving the patient's quality of life.

Detailed description

Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%.Multiple treatment modalities are currently available, ranging from non-invasive pharmacologic options to minimally invasive techniques such as extracorporeal shockwave lithotripsy (ESWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL). Treatment selection is primarily guided by stone size, location, and complexity. Importantly, the chosen intervention should aim to achieve a high stone-free rate (SFR) with the lowest possible complication rate. Minimally invasive technique is considered the first-line of treatment for renal stones in children due to its favorable safety profile and minimally invasive nature. In such cases, endourological options like RIRS and mini-PCNL serve as favourable line of treatments. RIRS is a minimally invasive procedure that offers advantages such as reduced perioperative morbidity, lower bleeding risk, and quicker recovery compared to mini PCNL. Nonetheless, its stone clearance rate may be inferior to mini PCNL, particularly for larger stones. RIRS often requires DJ stenting and may lead to repeated interventions, which can result in lower urinary tract symptoms (LUTS) and negative impact on quality of life. Mini-PCNL, although highly effective, carries a higher risk of complications, including bleeding and adjucnt oragan injury particularly due to tract dilation.To reduce these risks, modified PCNL techniques have been introduced, such as ultramini-PCNL, and micro-PCNL. These smaller-caliber systems have demonstrated greater safety profiles in children and higher efficacy than ESWL, making them promising in pediatric stone management.

Interventions

PROCEDURERetrograde Intrarenal Surgery

to compare the efficacy and safety of retrograde intrarenal surgery (RIRS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the management of renal stones ≤2 cm in pediatric patients.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children aged 1 to 18 years . * Presence of a renal stone ≤2 cm in maximum diameter (single or multiple). * Stone located in the renal pelvis and/or calyces. * Normal renal function (based on age-adjusted serum creatinine and/or eGFR). * No prior surgical intervention for the current stone episode.

Exclusion criteria

* Anatomical abnormalities of the urinary tract (e.g., ureteropelvic junction obstruction, horseshoe kidney). * Bleeding disorders or uncorrected coagulopathy. * Active urinary tract infection at the time of surgery. * Patients with contraindications to general anesthesia.

Design outcomes

Primary

MeasureTime frameDescription
Measure Stone-Free Rate:6 monthsDefined as the absence of residual stones or the presence of clinically insignificant residual fragments (CIRF) \<4 mm or absent and this will be better results, but if Clinical significant residual fragments \> or Equal 4 mm may need Auxillary procedure Evaluation the patients after the operation by Stone-Free Rate as an indicator of surgical success.

Countries

Egypt

Contacts

CONTACTMostafa Mahmoud Rashed Ali, M.D
Mostafarashed2222@gmail.com+20111049435
CONTACTAtef Fathi Ali, professor
Ateffathi2010@yahoo.com+201099051714
STUDY_CHAIRGamal Abdelhamid Alsagheer, Professor

Urology Department, Faculty of Medicine, South Valley University.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026