Ureter StoneNCT06147817
Ureteral Stones in Children; What Has Changed With the Increase in Experience?
An observational study of Ureter Stone and Childhood, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 9 months to 17 years
- Conditions the study is for
- Ureter Stone, Childhood
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- children with ureteral stones who were operated on in our clinic
Who cannot join
- • The exclusion criteria were cases that were converted to open surgery, cases in which URS could not be performed because of anatomical reasons,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ureteroscopy With Holmium:YAG Laser Lithotripsy for Ureteral Stones in Children; What Has Changed With the Increase in Experience?
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.
- Conditions
- Ureter Stone, Childhood
- Keywords
- Ureter Stone, Children, Complication, Stone Free Rate
- Medical subject headings
- Ureterolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Perioperative and postoperative first month data from two different periods will be compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureter StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğrul Tiryaki, Ankara City Hospital Bilkent
- Investigators
- Huseyin T Tiryaki, MD, Study director, University of Health Science Ankara Bilkent City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147817
- Sponsor's protocol ID
- E-2-23-5304
- Status last verified
- Oct 2024
- First submitted
- 14 Nov 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Describe the IPD sharing plan, including what IPD are to be shared with other researchers.
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteroscopy With Holmium:YAG Laser Lithotripsy for Ureteral Stones in Children; What Has Changed With the Increase in Experience?
- ClinicalTrials.gov ID
- NCT06147817
- Acronym / sponsor ID
- E-2-23-5304
- Conditions
- Ureter Stone, Childhood
- Keywords
- Ureter Stone, Children, Complication, Stone Free Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 9 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- children with ureteral stones who were operated on in our clinic
Key exclusion criteria (1 listed)
- • The exclusion criteria were cases that were converted to open surgery, cases in which URS could not be performed because of anatomical reasons,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of stone-free rate in children who underwent ureteroscopy (URS) for ureter stone
Time frame: Ultrasonography evaluation was performed postoperative 1. month, 3-6-12-18 months, and ureter stones of the patients were evaluated.
After the ureteroscopy, patients were monitored with Ultrasonography in the first month, 3-6-12 months, and stone-free rates were determined.
Rate of complication in children who underwent URS for ureter stone
Time frame: Evaluation include postoperative 1. month
Perioperative and postoperative complications noted
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.
Time frame: Perioperative and postoperative first month data from two different periods will be compared
The effect of experience on the results was determined by comparing the complications percentage and stone-free percentage of the two periods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 23465154Tiryaki 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.
- Individual participant dataSharing planned: No. Describe the IPD sharing plan, including what IPD are to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huseyin T Tiryaki, MD study director
University of Health Science Ankara Bilkent City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureter Stone and Childhood, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of stone-free rate in children who underwent ureteroscopy (URS) for ureter stone (time frame: Ultrasonography evaluation was performed postoperative 1. month, 3-6-12-18 months, and ureter stones of the patients were evaluated.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.