ClinicalTrials.gg
RecruitingNCT07700251Updated Jul 14, 2026

Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy

An interventional study of Retrograde Intrarenal Surgery in Pediatric Renal Stone, sponsored by South Valley University. Recruiting at 1 site in Egypt. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Aug 2025, registered Jul 2026).
  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pediatric Renal Stone
03

In context

Lead sponsor

South Valley University is the lead sponsor of 153 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ).
  • No prior surgical intervention for the current stone episode.

Exclusion criteria

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 to general anesthesia.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Percutaneous Nephrolithotomy Group

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

    Procedure: Retrograde Intrarenal Surgery

  • Active comparator
    Retrograde Intrarenal Surgery Group

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

    Procedure: Retrograde Intrarenal Surgery

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.

    Also known as: mini Percutaneous Nephrolithotomy

06

What researchers measure

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 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Aug 2026, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2026
First posted
Jul 14, 2026
StartActual
Aug 1, 2025
Primary completionEst.
Aug 1, 2026
CompletionEst.
Aug 10, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07700251
Responsible party
Mostafa Mahmoud Rashed Aly (Lecturer at Urology Department, Faculty of Medicine, South Valley University) — Principal investigator
First posted
Jul 14, 2026
Start date
Aug 1, 2025
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 10, 2026 (estimated)
Last update
Jul 14, 2026

Study contacts

Mostafa Mahmoud Rashed Ali, M.D
Contact
Mostafarashed2222@gmail.com
+20111049435
Atef Fathi Ali, professor
Contact
Ateffathi2010@yahoo.com
+201099051714
Gamal Abdelhamid Alsagheer, Professor
study chair · Urology Department, Faculty of Medicine, South Valley University.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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