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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Renal Stone
• Intervention / Treatment: Procedure: Retrograde Intrarenal Surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Mahmoud Rashed Ali, M.D; Phone Number: +20111049435; Email: Mostafarashed2222@gmail.com
• Study Contact Backup: Name: Atef Fathi Ali, professor; Phone Number: +201099051714; Email: Ateffathi2010@yahoo.com

Study Locations

• Egypt
  • South Valley
    • Qina, South Valley, Egypt
      • Recruiting
      • South Valley University Hospital
      • Contact: Gamal Abdelhamid Alsagheer, Professor; Phone Number: +201062487020; Email: alsagheer@med.svu.edu.eg
      • Contact: Omar Mohamed El-Saghir, Assist.Prof; Phone Number: +201095421734; Email: Omarelsoqier1983@med.svu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous Nephrolithotomy Group; About 30 child suffering from renal stone will undergo mini percutaneous nephrolithotomy	Procedure: Retrograde 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.; Other Names: mini Percutaneous Nephrolithotomy
Active Comparator: Retrograde Intrarenal Surgery Group; About 30 child suffering from renal stone will undergo retrograde intrarenal surgery	Procedure: Retrograde 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.; Other Names: mini Percutaneous Nephrolithotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Study Chair: Gamal Abdelhamid Alsagheer, Professor, Urology Department, Faculty of Medicine, South Valley University.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 10, 2026

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pediatric Renal Stone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No