NCT06147817

Brief Summary

With advances in endourological equipment, minimally invasive procedures have been found to be sufficient for the treatment of ureteral stones in children. The investigators aimed to evaluate the stone-free rate and complications related to the procedure and to compare it with the period when their experience were limited by presenting their patients with ureteral stones treated by ureteroscopy (URS) and holmium YAG laser in the last three years after their 15-year routine endourological practice. The investigators retrospectively compared 54 cases treated with ureteroscopy (URS) for ureteral stones between 2009-2011, the first three years of our endourological interventions in children, and 78 cases treated with URS for ureteral stones between 2020-2022, the last three years of their 15-year endourological experience, from hospital records. Demographic data, stone-free rates, number of procedures and recorded complications were evaluated in both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

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
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

November 14, 2023

Last Update Submit

October 21, 2024

Conditions

Keywords

Ureter StoneChildrenComplicationStone Free Rate

Outcome Measures

Primary Outcomes (3)

  • Determination of stone-free rate in children who underwent ureteroscopy (URS) for ureter stone

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

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

  • Rate of complication in children who underwent URS for ureter stone

    Perioperative and postoperative complications noted

    Evaluation include postoperative 1. month

  • The stone-free percentages and complications percentages detected in the period when endoscopic procedures were started and in the last period when experience increased were compared.

    The effect of experience on the results was determined by comparing the complications percentage and stone-free percentage of the two periods.

    Perioperative and postoperative first month data from two different periods will be compared

Eligibility Criteria

Age9 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Between 01 01 2020 and 31 12 2022, 78 children with ureteral stones who were operated on in our clinic were retrospectively evaluated from the hospital records. A total of 40 males and 38 females with a mean age of 9,64+4,91 years (range 0.75 to 17) required surgical treatment for ureteral stones.

You may qualify if:

  • children with ureteral stones who were operated on in our clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Tiryaki T, Azili MN, Ozmert S. Ureteroscopy for treatment of ureteral stones in children: factors influencing the outcome. Urology. 2013 May;81(5):1047-51. doi: 10.1016/j.urology.2013.01.008. Epub 2013 Mar 7.

    PMID: 23465154BACKGROUND

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

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

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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor, Director of Pediatric Urology Training

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 28, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2022

Study Completion

October 31, 2023

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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

Locations