Renal StoneNCT06138704
Evaluation of Retrograde Intrarenal Surgery Results and Stone-free Rate in Children With Kidney Stones
An observational study of Renal Stone and Retrograde Intrarenal Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Renal Stone, Retrograde Intrarenal Surgery
- What is being tested?
- Retrograde Intrarenal Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Oct 2023
- How long will I take part?
- 2 Years
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- The inclusion criteria were pediatric patients with kidney stones who underwent RIRS.
Who cannot join
- The exclusion criteria were cases that were converted to open surgery, cases in which RIRS could not be performed because of anatomical reasons, and cases in which lower pole stones could not be reached with RIRS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrograde Intrarenal Surgery Results and Stone-free Rate in Children With Kidney Stones
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
Read the detailed description
There has been a worldwide rise in the prevalence of urolithiasis in children, which is linked to changes in lifestyle and dietary habits, climate changes, childhood obesity, and the increased availability of ultrasonography (1). In pediatric stone disease, it is crucial to evaluate the underlying reasons, which may include metabolic disorders, anatomical anomalies, and infection, to avoid higher recurrence of stones after treatment (2). The increasing incidence and recurrence of this disease highlights the necessity for minimally invasive therapeutic solutions. Retrograde intrarenal surgery (RIRS) is gaining new indications owing to advanced laser and endoscopic technology, resulting in a constant rise in the number of procedures (3).
Routine RIRS has been performed in our clinic for the last 15 years with increasing rates. Patients in whom RIRS has been performed in the last three 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 between January 2019 and December 2022 at the Ankara Bilkent City Hospital, University of Health Science, Ankara, Turkey. The inclusion criteria were pediatric patients with kidney stones who underwent RIRS. The exclusion criteria were cases that were converted to open surgery, cases in which RIRS could not be performed because of anatomical reasons, and cases in which lower pole stones could not be reached with RIRS. The Ethics Committee of the Institution approved this study (E2-23-5305). All patient details were identified, and all patients provided written informed consent to participate in the study. Medical history, serum electrolytes, midstream urine culture, urinalysis, serum creatinine, complete blood count, and coagulation assessments were performed preoperatively. Plain abdominal film and ultrasonography/computer tomography scan examinations were also performed. Patients with preoperative positive urine culture results received a complete course of culture-specific antibiotics before RIRS Prophylactic antibiotic treatment with cephazolin was administered to all patients prior to surgery.
Surgical treatment was indicated when there was an obstruction, infection, failure of spontaneous stone passage, or stones larger than 7 mm and in the presence of increasing or unremitting colic.
All RIRS procedures were performed under general anesthesia with direct videoscopic and fluoroscopic guidance. All procedures were performed by the same surgeon. Semirigid ureteroscopy (4.5 Fr R. Wolf, Knittlingen, Germany) or flexible ureteroscopy (Karl Storz FLEX-X, Tuttlingen, Germany) was performed to place an access sheath. The decision to use a flexible or semirigid ureteroscope depended on the location of the stones. A flexible ureteroscope was used for lower pole stone, wherease a semirigid ureteroscope was preferred for renal pelvic or upper pole stones. In our practice, all children undergoing RIRS for stone disease received cephazolin. Perioperative antibiotic treatment was continued for a week following surgery. If a double J (JJ) stent was inserted, antibiotic prophylaxis was continued and ceased after removal of the JJ stent. A manual irrigation pump system was used for hydrodilation of the ureter during ureterorenoscopy. If this was not enough to pass the ureteroscope, the investigators placed a JJ catheter for passive dilatation. Ureteral active coaxial or balloon dilation was not performed. The investigators used isotonic fluid at body temperature to avoid hypothermia and hyponatremia during the procedures. The urinary bladder was maintained at low pressure with a 14-F suprapubic angiocatheter in all patients. Stones were fragmented using a holmium-YAG laser (Litho Quanta System, Italy) 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. The decision to place a postoperative uretral stent was made according to visible mucosal ureteral trauma or edema at the end of the procedure. The extracted stone specimens were submitted for stone analysis. All patients were discharged if fever was not detected the day after the procedures. Medical therapy and dietary planning were provided postoperatively on the basis of the composition of the stones. Ultrasonography (USG) was performed three months, six months, and one year after the procedures to evaluate stone recurrence and hydronephrosis. The investigators analyzed the stone-free rate, complications, and conversion to the open procedure. Statistical analysis was performed using the Chi-Square and ANOVA tests, p: 0.05 was considered statistically significant.
- Conditions
- Renal Stone, Retrograde Intrarenal Surgery
- Being tested
- Retrograde Intrarenal Surgery
- Keywords
- Kidney Stone, Retrograde Intrarenal Surgery, Children, Stone Free Rate
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Intrarenal SurgeryProcedure or surgery
Also called Lithohtrapsy
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.
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 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.
Measured: 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?
Patients first month after RIRS, 3-6-12. It was determined by follow-up with USG over the months and when stone-free status was achieved.
Measured: 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.
The effects of gender, age, number of stones, presence of staghorn stones, and whether a JJ stent was placed before the procedure on stone-free rates were evaluated in pediatric patients who underwent RIRS due to kidney stones.
Measured: 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
The presence of additional interventions to ensure stone-free status was evaluated from hospital records.
Measured: Evaluating 4-year hospital records of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 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 (4)Papers the sponsor has linked to this study.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 105 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huseyin T Tiryaki, MD, Study director, University of Health Science Ankara Bilkent City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138704
- Sponsor's protocol ID
- E2-23-5305
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2023
- Last updated
- 11 Dec 2023
- 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
Clayton DB, Pope JC. The increasing pediatric stone disease problem. Ther Adv Urol. 2011 Feb;3(1):3-12. doi: 10.1177/1756287211400491.
PubMed 21789094Copelovitch 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.
PubMed 22857835Azili 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.
PubMed 24952809Karagoz 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.
PubMed 32395324
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Intrarenal Surgery Results and Stone-free Rate in Children With Kidney Stones
- ClinicalTrials.gov ID
- NCT06138704
- Acronym / sponsor ID
- E2-23-5305
- Conditions
- Renal Stone, Retrograde Intrarenal Surgery
- Keywords
- Kidney Stone, Retrograde Intrarenal Surgery, Children, Stone Free Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 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
- 18 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.
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
Detailed description
There has been a worldwide rise in the prevalence of urolithiasis in children, which is linked to changes in lifestyle and dietary habits, climate changes, childhood obesity, and the increased availability of ultrasonography (1). In pediatric stone disease, it is crucial to evaluate the underlying reasons, which may include metabolic disorders, anatomical anomalies, and infection, to avoid higher recurrence of stones after treatment (2). The increasing incidence and recurrence of this disease highlights the necessity for minimally invasive therapeutic solutions. Retrograde intrarenal surgery (RIRS) is gaining new indications owing to advanced laser and endoscopic technology, resulting in a constant rise in the number of procedures (3).
Routine RIRS has been performed in our clinic for the last 15 years with increasing rates. Patients in whom RIRS has been performed in the last three 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 between January 2019 and December 2022 at the Ankara Bilkent City Hospital, University of Health Science, Ankara, Turkey. The inclusion criteria were pediatric patients with kidney stones who underwent RIRS. The exclusion criteria were cases that were converted to open surgery, cases in which RIRS could not be performed because of anatomical reasons, and cases in which lower pole stones could not be reached with RIRS. The Ethics Committee of the Institution approved this study (E2-23-5305). All patient details were identified, and all patients provided written informed consent to participate in the study. Medical history, serum electrolytes, midstream urine culture, urinalysis, serum creatinine, complete blood count, and coagulation assessments were performed preoperatively. Plain abdominal film and ultrasonography/computer tomography scan examinations were also performed. Patients with preoperative positive urine culture results received a complete course of culture-specific antibiotics before RIRS Prophylactic antibiotic treatment with cephazolin was administered to all patients prior to surgery.
Surgical treatment was indicated when there was an obstruction, infection, failure of spontaneous stone passage, or stones larger than 7 mm and in the presence of increasing or unremitting colic.
All RIRS procedures were performed under general anesthesia with direct videoscopic and fluoroscopic guidance. All procedures were performed by the same surgeon. Semirigid ureteroscopy (4.5 Fr R. Wolf, Knittlingen, Germany) or flexible ureteroscopy (Karl Storz FLEX-X, Tuttlingen, Germany) was performed to place an access sheath. The decision to use a flexible or semirigid ureteroscope depended on the location of the stones. A flexible ureteroscope was used for lower pole stone, wherease a semirigid ureteroscope was preferred for renal pelvic or upper pole stones. In our practice, all children undergoing RIRS for stone disease received cephazolin. Perioperative antibiotic treatment was continued for a week following surgery. If a double J (JJ) stent was inserted, antibiotic prophylaxis was continued and ceased after removal of the JJ stent. A manual irrigation pump system was used for hydrodilation of the ureter during ureterorenoscopy. If this was not enough to pass the ureteroscope, the investigators placed a JJ catheter for passive dilatation. Ureteral active coaxial or balloon dilation was not performed. The investigators used isotonic fluid at body temperature to avoid hypothermia and hyponatremia during the procedures. The urinary bladder was maintained at low pressure with a 14-F suprapubic angiocatheter in all patients. Stones were fragmented using a holmium-YAG laser (Litho Quanta System, Italy) 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. The decision to place a postoperative uretral stent was made according to visible mucosal ureteral trauma or edema at the end of the procedure. The extracted stone specimens were submitted for stone analysis. All patients were discharged if fever was not detected the day after the procedures. Medical therapy and dietary planning were provided postoperatively on the basis of the composition of the stones. Ultrasonography (USG) was performed three months, six months, and one year after the procedures to evaluate stone recurrence and hydronephrosis. The investigators analyzed the stone-free rate, complications, and conversion to the open procedure. Statistical analysis was performed using the Chi-Square and ANOVA tests, p: 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- The inclusion criteria were pediatric patients with kidney stones who underwent RIRS.
Key exclusion criteria (1 listed)
- The exclusion criteria were cases that were converted to open surgery, cases in which RIRS could not be performed because of anatomical reasons, and cases in which lower pole stones could not be reached with RIRS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrograde Intrarenal SurgeryAlso: LithohtrapsyAll 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. | Procedure or surgery | – |
Primary outcome
Determination of stone-free rate in children who underwent lithotripsy with retrograde intrarenal surgery for kidney stones.
Time frame: USG evaluation was performed postoperative 1. month, 3-6-12-18 months, and kidney stones of the patients were evaluated.
After the RIRS, patients were monitored with USG in the first month, 3-6-12 months, and stone-free rates were determined.
3 secondary outcomes
How long does it take for renal stones to be cleared after RIRS?
Time frame: 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.
Time frame: 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
Time frame: Evaluating 4-year hospital records of patients
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 11 Dec 2023.
- Background: PubMed 21789094Clayton DB, Pope JC. The increasing pediatric stone disease problem. Ther Adv Urol. 2011 Feb;3(1):3-12. doi: 10.1177/1756287211400491.
- Background: PubMed 22857835Copelovitch 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.
- Background: PubMed 24952809Azili 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.
- Results publication: PubMed 32395324Karagoz 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.
- 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 Renal Stone and Retrograde Intrarenal Surgery, 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 11 Dec 2023. 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 lithotripsy with retrograde intrarenal surgery for kidney stones. (time frame: USG evaluation was performed postoperative 1. month, 3-6-12-18 months, and kidney stones of the patients were evaluated.). 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 NCT06138704, which also lists 4 linked publications.
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 11 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.