Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy
ConditionPediatric Renal Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSouth Valley University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Retrograde Intrarenal Surgery
Procedure/Surgeryto 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Percutaneous Nephrolithotomy GroupActive comparator 1 intervention
Group B: Retrograde Intrarenal Surgery GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Measure Stone-Free Rate:
Defined 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.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov