NCT07836192

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Mini Percutaneous NephrolithotomyRetrograde Intrarenal SurgeryPediatricRenal Stones

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications

    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.

    24 hours postoperatively

Secondary Outcomes (4)

  • Operative time

    Up to 3 hours

  • Fluoroscopy time

    Intraoperatively

  • Postoperative stenting

    Immediately after the procedure (Up to 2 hours)

  • Lenght of hospital stay

    Till the discharge from hospital (Up to 2 weeks)

Study Arms (2)

Mini PCNL

EXPERIMENTAL

Patients underwent mini percutaneous nephrolithotomy (PCNL) technique.

Procedure: Mini percutaneous nephrolithotomy

FURS

EXPERIMENTAL

Patients underwent single use flexible ureteroscopy (FURS).

Procedure: Flexible ureteroscopy

Interventions

Flexible ureteroscopyPROCEDURE

Patients underwent single use flexible ureteroscopy (FURS).

FURS
Mini percutaneous nephrolithotomyPROCEDURE

Patients underwent mini percutaneous nephrolithotomy (PCNL) technique.

Mini PCNL

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

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 of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start

July 1, 2021

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)