NephrolithiasisNCT04299204
The Success of Pediatric Percutaneous Nephrolithotomy
A study testing Percutaneous nephrolitotomy in people with Nephrolithiasis, run by Osmaniye Government Hospital.
Trial summary
Between June 1997-June 2018, 573 pediatric patients underwent PCNL for renal stone disease by senior surgeons. Data was disunited into 2 groups. The study showed that PCNL is an operator-dependent procedure, with the improvement of outcomes over time, presumably due to increased operator experience and the involvement… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Percutaneous nephrolitotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 553 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 1998to 1 Jul 2018
- Phase
- Interventional
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with kidney stone
Who cannot join
- Patients with a solitary kidney
About this study
Official title: Which Factor Affect the Success of Pediatric PCNL?: Single Center Experiences, Over 20 Years: Cohort Study
Between June 1997-June 2018, 573 pediatric patients underwent PCNL for renal stone disease by senior surgeons. Data was disunited into 2 groups.
The study showed that PCNL is an operator-dependent procedure, with the improvement of outcomes over time, presumably due to increased operator experience and the involvement of a team member with substantial prior experience During 20 years, by gaining experience and with the development of new tools and optics, fluoroscopy time, operation time, blood loss and complication rates decreased and stone-free rates increased.
- Conditions
- Nephrolithiasis
- Being tested
- Percutaneous nephrolitotomy
- Keywords
- Urolithiasis, Pediatrics, Percutaneous
- Medical subject headings
- Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolitotomyProcedure or surgery
Pediatric PCNL
| Study group | Role | What they receive |
|---|---|---|
| Years 1997-2007 | Experimental | Group-1, PCNL was performed in the first 10 years period (Years 1997-2007); Receives: Procedure: Percutaneous nephrolitotomy |
| 2008- to the present | Experimental | The PCNL was performed in the second ten years period from 2008 to the present. Receives: Procedure: Percutaneous nephrolitotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of clinical experience of Percutaneous nephrolitotomy
The duration of clinical experience affects complication rates, success rates. Intraoperative and postoperative data was contained, preoperative and postoperative GFR (calculated with Cockcroft Gault equations), changing hemoglobin levels, transfusion rate, complications according to the Clavien classification.
Measured: over 20 years
Secondary outcomes (1)
Changing of complications managements
Rate of and changing of Management of complications in pediatric patients
Measured: Over 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start15 Jan 1998
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
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 NephrolithiasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- the data into two groups. In group-1, PCNL was performed in the first 10 years period (1997-2007); in group-2, PCNL was performed in the second ten years period from 2008 to the present.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Government Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299204
- Sponsor's protocol ID
- OsmaniyeGH
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data belonged to Cukurova University, Department of Urology
Publications
Citamak B, Altan M, Bozaci AC, Koni A, Dogan HS, Bilen CY, Sahin A, Tekgul S. Percutaneous Nephrolithotomy in Children: 17 Years of Experience. J Urol. 2016 Apr;195(4 Pt 1):1082-7. doi: 10.1016/j.juro.2015.11.070. Epub 2015 Dec 9.
PubMed 26682755
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Factor Affect the Success of Pediatric PCNL?: Single Center Experiences, Over 20 Years: Cohort Study
- ClinicalTrials.gov ID
- NCT04299204
- Acronym / sponsor ID
- OsmaniyeGH
- Conditions
- Nephrolithiasis
- Keywords
- Urolithiasis, Pediatrics, Percutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Osmaniye Government HospitalOther government
- Study start
- 15 Jan 1998 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 6 Mar 2020 (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.
Between June 1997-June 2018, 573 pediatric patients underwent PCNL for renal stone disease by senior surgeons. Data was disunited into 2 groups.
The study showed that PCNL is an operator-dependent procedure, with the improvement of outcomes over time, presumably due to increased operator experience and the involvement of a team member with substantial prior experience During 20 years, by gaining experience and with the development of new tools and optics, fluoroscopy time, operation time, blood loss and complication rates decreased and stone-free rates increased.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- the data into two groups. In group-1, PCNL was performed in the first 10 years period (1997-2007); in group-2, PCNL was performed in the second ten years period from 2008 to the present.
| Arm | Type | Receives |
|---|---|---|
| Years 1997-2007 | Experimental | Procedure: Percutaneous nephrolitotomyGroup-1, PCNL was performed in the first 10 years period (Years 1997-2007); |
| 2008- to the present | Experimental | Procedure: Percutaneous nephrolitotomyThe PCNL was performed in the second ten years period from 2008 to the present. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients with kidney stone
Key exclusion criteria (1 listed)
- Patients with a solitary kidney
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 |
|---|---|---|
| Percutaneous nephrolitotomyPediatric PCNL | Procedure or surgery | 2008- to the present, Years 1997-2007 |
Primary outcome
Safety and Efficacy of clinical experience of Percutaneous nephrolitotomy
Time frame: over 20 years
The duration of clinical experience affects complication rates, success rates. Intraoperative and postoperative data was contained, preoperative and postoperative GFR (calculated with Cockcroft Gault equations), changing hemoglobin levels, transfusion rate, complications according to the Clavien classification.
1 secondary outcome
Changing of complications managements
Time frame: Over 20 years
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 6 Mar 2020.
- Results publication: PubMed 26682755Citamak B, Altan M, Bozaci AC, Koni A, Dogan HS, Bilen CY, Sahin A, Tekgul S. Percutaneous Nephrolithotomy in Children: 17 Years of Experience. J Urol. 2016 Apr;195(4 Pt 1):1082-7. doi: 10.1016/j.juro.2015.11.070. Epub 2015 Dec 9.
- Individual participant dataSharing planned: Undecided. The data belonged to Cukurova University, Department of Urology
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nephrolitotomy in people with Nephrolithiasis, run by Osmaniye Government Hospital.
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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety and Efficacy of clinical experience of Percutaneous nephrolitotomy (time frame: over 20 years). 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 NCT04299204, 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 6 Mar 2020.