NCT06138704

Brief Summary

There is a global increase in the prevalence of urolithiasis in children attributed to lifestyle changes, dietary habits, climate changes, childhood obesity, and the wider availability of ultrasonography. The rising incidence of the disease with its recurrent nature emphasizes the need for minimally invasive therapeutic options. Patients in whom RIRS has been performed in the last four years with increasing experience will be presented, and complications, stone-free rates, and technical details will be discussed. This retrospective Cohort study included children who underwent RIRS. Medical history, serum electrolytes, midstream urine culture, urinalysis, serum creatinine, complete blood count, and coagulation assessments were performed preoperatively. Ultrasonography (USG) was performed three months, 6 months, and 1 year after the procedures to evaluate stone recurrence and hydronephrosis. The investigators analyzed the stone-free rate ,complications, and the conversion to open procedure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

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

January 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

4 years

First QC Date

November 14, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

Kidney StoneRetrograde Intrarenal SurgeryChildrenStone Free Rate

Outcome Measures

Primary Outcomes (1)

  • Determination of stone-free rate in children who underwent lithotripsy with retrograde intrarenal surgery for kidney stones.

    After the RIRS, patients were monitored with USG in the first month, 3-6-12 months, and stone-free rates were determined.

    USG evaluation was performed postoperative 1. month, 3-6-12-18 months, and kidney stones of the patients were evaluated.

Secondary Outcomes (3)

  • How long does it take for renal stones to be cleared after RIRS?

    USG evaluation was performed postoperative 1. month, 3-6-12-18 months, and kidney stones of the patients were evaluated.

  • Determination of factors affecting stone-free rate in pediatric patients who underwent RIRS due to kidney stones.

    USG evaluation was performed postoperative 1. month, 3-6-12-18 months, and kidney stones of the patients were evaluated.

  • Determining the need for repeated interventions to ensure stone-free status

    Evaluating 4-year hospital records of patients

Other Outcomes (1)

  • Determination of procedure-related complications in pediatric patients who underwent RIRS due to kidney stones.

    Evaluating 4-year hospital records of patients

Interventions

All RIRS procedures were performed under general anesthesia with direct videoscopic and fluoroscopic guidance. The decision to use a flexible or semirigid ureteroscope depended on the location of the Stones. If this was not enough to pass the ureteroscope, we placed a JJ catheter for passive dilatation. Stones were fragmented using a holmium-YAG laser and grasped by a stone basket when applicable. Contrast injection was performed at the end of the procedures to confirm the absence of extravasation and stone-free status. Ultrasonography (USG) was performed three months, six months, and one year after the procedures to evaluate stone recurrence and hydronephrosis.

Also known as: Lithohtrapsy

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

One hundred and five patients (49 boys and 56 girls) with a median age of 6,66+5,27 years (0,25-17,6 years) were treated with RIRS between January 2019 and December 2022. The RIRS procedure could not be performed in 15 cases, whereas it could be performed in 90 cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Clayton DB, Pope JC. The increasing pediatric stone disease problem. Ther Adv Urol. 2011 Feb;3(1):3-12. doi: 10.1177/1756287211400491.

    PMID: 21789094BACKGROUND
  • Copelovitch L. Urolithiasis in children: medical approach. Pediatr Clin North Am. 2012 Aug;59(4):881-96. doi: 10.1016/j.pcl.2012.05.009. Epub 2012 Jun 15.

    PMID: 22857835BACKGROUND
  • Azili MN, Ozcan F, Tiryaki T. Retrograde intrarenal surgery for the treatment of renal stones in children: factors influencing stone clearance and complications. J Pediatr Surg. 2014 Jul;49(7):1161-5. doi: 10.1016/j.jpedsurg.2013.12.023. Epub 2014 Jan 13.

    PMID: 24952809BACKGROUND
  • Karagoz MA, Erihan IB, Doluoglu OG, Ugurlu C, Bagcioglu M, Uslu M, Sarica K. Efficacy and safety of fURS in stones larger than 20 mm: is it still the threshold? Cent European J Urol. 2020;73(1):49-54. doi: 10.5173/ceju.2020.0056. Epub 2020 Jan 3.

MeSH Terms

Conditions

NephrolithiasisKidney Calculi

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Huseyin T Tiryaki, MD

    University of Health Science Ankara Bilkent City Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2022

Study Completion

October 31, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Describe the IPD sharing plan, including what IPD are to be shared with other researchers.

Locations