Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy

NCT07700251 | Recruiting DMC

• 1 other identifier: Pediatric Renal Stone
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Renal Stone

Outcome Measures

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.

  6 months

Study Arms (2)

Percutaneous Nephrolithotomy Group

ACTIVE COMPARATOR

About 30 child suffering from renal stone will undergo mini percutaneous nephrolithotomy

Procedure: Retrograde Intrarenal Surgery

Retrograde Intrarenal Surgery Group

ACTIVE COMPARATOR

About 30 child suffering from renal stone will undergo retrograde intrarenal surgery

Procedure: Retrograde Intrarenal Surgery

Interventions

Retrograde Intrarenal Surgery PROCEDURE

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.

Also known as: mini Percutaneous Nephrolithotomy

Percutaneous Nephrolithotomy Group; Retrograde Intrarenal Surgery Group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University Hospital

Qina, South Valley, Egypt

RECRUITING

Study Officials

• Gamal Abdelhamid Alsagheer, Professor

  Urology Department, Faculty of Medicine, South Valley University.

  STUDY CHAIR

Central Study Contacts

Mostafa Mahmoud Rashed Ali, M.D

CONTACT

+20111049435; Mostafarashed2222@gmail.com

Atef Fathi Ali, professor

CONTACT

+201099051714; Ateffathi2010@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Urology Department, Faculty of Medicine

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: July 14, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)