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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara

Other trials in Turkey (Türkiye)

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.

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.

  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.

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

Secondary outcomes (3)
  1. 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.

  2. 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.

  3. 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.

  1. First posted18 Nov 2023
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Oct 2023

Resources

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
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 21789094
  • 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.

    PubMed 22857835
  • 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.

    PubMed 24952809
  • 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.

    PubMed 32395324

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.

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