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NCT Number: NCT07836192

Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery for Pediatric Renal Stones (10-30 mm)

This work aimed to compare the safety and efficacy of retrograde intrarenal surgery using single-use flexible ureteroscopy (FURS) with mini-percutaneous nephrolithotomy (PCNL) in children with renal stones measuring 10-30 mm.

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Key information

Conditions

Mini Percutaneous Nephrolithotomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pediatric Renal Stones Retrograde Intrarenal Surgery Urogenital Diseases Urolithiasis Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Children have a smaller pelvicalyceal system, more delicate tissues, and a more curved ureter compared to adults.

While percutaneous nephrolithotomy (PCNL) offers excellent stone-free rates for large stones (>2 cm), its application in children presents challenges due to their smaller renal anatomy and increased kidney mobility.

Retrograde intrarenal surgery with flexible ureteroscopy (FURS) major advantage lies in utilizing natural orifices, eliminating the need for additional access routes with theoretically enhanced faster postoperative recovery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children <18 years old.
  • Both sexes.
  • Single calyceal renal stone of 10-20 mm in maximum diameter, single renal pelvic stone of 10-20 in maximum diameter with history of failed, extracorporeal shock wave lithotripsy (ESWL) or refused ESWL, single renal stone 20-30 mm in maximum diameter and multiple renal stones with total stone size 10-30 mm (sum of maximum dimensions of each stone).

Exclusion criteria

  • Patients with uncorrected coagulopathy.
  • Renal or ureteral malformation.
  • Cases with significant anatomical obstruction requiring separate intervention or associated metabolic disorder.

Treatment and study plan

Mini Percutaneous Nephrolithotomy

Procedure

Patients underwent mini percutaneous nephrolithotomy (PCNL) technique.

flexible ureteroscopy

Procedure

Patients underwent single use flexible ureteroscopy (FURS).

Primary outcomes

  1. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications will be recorded according to the Clavien-Dindo grading system.

    The Grades of the Clavien-Dindo Classification:

    • Grade I: Any deviation from the normal postoperative course. It does not need pharmacological treatment or surgical, endoscopic, and radiological interventions.
    • Grade II: Requires pharmacological treatment with drugs other than those allowed for Grade I. Blood transfusions and total parenteral nutrition.
    • Grade III: Requires surgical, endoscopic, or radiological intervention. Grade IIIa: Intervention done without general anesthesia. Grade IIIb: Intervention done under general anesthesia.
    • Grade IV: Life-threatening complication requiring intermediate or intensive care unit management. Grade IVa: Single-organ dysfunction. Grade IVb: Multi-organ failure.
    • Grade V: Death of the patient.

Secondary outcomes

  1. Operative time

    Time frame: Up to 3 hours

    Operative time will be recorded from start till the end of surgery.

  2. Fluoroscopy time

    Time frame: Intraoperatively

    Total duration of fluoroscopy exposure during the procedure will be measured in seconds, from the first fluoroscopic image until the final image

  3. Postoperative stenting

    Time frame: Immediately after the procedure (Up to 2 hours)

    Percentage of participants requiring ureteral stent placement after the procedure will be recorded.

  4. Lenght of hospital stay

    Time frame: Till the discharge from hospital (Up to 2 weeks)

    Lenght of hospital stay will be recorded from the admission till the discharge from the hospital.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Prospective Randomized Comparison of Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery for Pediatric Renal Stones (10-30 mm)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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