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CompletedNCT06147817Updated Oct 23, 2024

Ureteral Stones in Children; What Has Changed With the Increase in Experience?

An observational study in Ureter Stone and Childhood, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 9 Months to 17 Years. Per ClinicalTrials.gov, last updated 2024-10-23.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
78
Ages
9 Months to 17 Years
Sex
All
01

Study 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.

Read the detailed description

Due to the changing diet habits and sedentary lifestyle, the investigators encountered urinary system stones more and more frequently in children. Ureteral stones in children are now routinely treated with endourological interventions with the introduction of thin ureteroscopes. Despite the developing endoscopy technology, the smaller ureter diameter in children than in adults requires more careful and meticulous intervention technically. The investigators have published that in their first 54 cases in which they started to use routine endourological methods in the treatment of ureteral stones in pediatric patients between 2009 and 2011, the investigators had a stone-free rate of 57%, a complication rate of 9.7%, and a conversion rate of 18.75% to open surgery in the first attempt. In the literature, it is seen that different results are given in terms of stone-free and complications after ureteroscopy treatment for ureteral stones in children. The investigators aimed to evaluate the stone-free rate and complications related to the procedure and compare it with the period when our experience was limited by presenting their patients with ureteral stones that the investigators treated with ureteroscopy and Holmium YAG laser in the last three years, following their 15-year-old endourological routine practice experience.

Between 01 01 2020 and 31 12 2022, 78 children with ureteral stones who were operated on in their 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. USG or computerized tomography was performed in all cases, and mean stone size was 6.58+2.94 mm. (range 3,5 to 20). When stones did not pass spontaneously, the patients were treated with ureteroscopic laser lithotripsy.

All ureteroscopic procedures were performed under general anesthesia. An initial cystoscopy was done with a 8 Fr Storz cystoscope. A working guide wire was placed and negotiated beyond the level of the stone. A 4,5 Fr semirigid ureteroscope was used in all cases. Calculi were fragmented using holmium YAG laser. Fragments were extracted using a stone basket or grasper. The decision to place an ureteric stent postoperatively was based on the degree of ureteral trauma. The extracted stone fragments were sent for chemical analysis and further medical treatment initiated when appropriate. In children in whom ureteroscopy was not possible due to inability to introduce the ureteroscope, an ureteric stent was placed for passive dilation and ureteroscopy repeated 3 week later. All ureteroscopic procedures were carried out under antibiotic cover. All children underwent routine ultrasonography and urine examination in the follow-up period.

Stone-free status was determined both endoscopically at the end of the procedure and radiologically (USG) at 3 months follow-up prior to outpatient review. Stone-free rate (SFR) was defined as fragments confrmed radiologically and at least 6 months passed since the previous operation.

02

Conditions studied

  • Ureter Stone
  • Childhood

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Keywords

  • Ureter Stone
  • Children
  • Complication
  • Stone Free Rate
03

In context

Ureterolithiasis

84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.

This study's enrollment of 78 is below the median of 136 across 13 observational studies indexed under Ureterolithiasis.

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Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.

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

04

Who can participate

Ages eligible
9 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

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 with ureteral stones who were operated on in our clinic

Exclusion criteria

Exclusion Criteria:

    • The exclusion criteria were cases that were converted to open surgery, cases in which URS could not be performed because of anatomical reasons,
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
78 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

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

  2. Rate of complication in children who underwent URS for ureter stone

    Perioperative and postoperative complications noted

    Time frame: Evaluation include postoperative 1. month

  3. 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.

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

07

Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Turkey
08

References and documents

Publications

  • 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. PubMed 23465154 ↗

Individual participant data

Plan to share: No — Describe the IPD sharing plan, including what IPD are to be shared with other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Dec 2022, 47 months.

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

Registered
Nov 14, 2023
First posted
Nov 28, 2023
StartActual
Jan 1, 2019
Primary completionActual
Dec 31, 2022
CompletionActual
Oct 31, 2023
Last update
Oct 23, 2024
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 Oct 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06147817
Responsible party
Tuğrul Tiryaki (Profesor, Director of Pediatric Urology Training, Ankara City Hospital Bilkent) — Principal investigator
First posted
Nov 28, 2023
Start date
Jan 1, 2019
Primary completion
Dec 31, 2022
Completion
Oct 31, 2023
Last update
Oct 23, 2024

Study contacts

Huseyin T Tiryaki, MD
study director · University of Health Science Ankara Bilkent City Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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