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NCT04299204 Clinical Trial

The Success of Pediatric Percutaneous Nephrolithotomy

Nephrolithiasis Clinical Trial

Official title:
Which Factor Affect the Success of Pediatric PCNL?: Single Center Experiences, Over 20 Years: Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04299204
Other study ID # OsmaniyeGH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 1998
Est. completion date July 1, 2018

Study information
Verified date March 2020
Source Osmaniye Government Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 553
Est. completion date July 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion Criteria:

- Pediatric patients with kidney stone

Exclusion Criteria:

- Patients with a solitary kidney

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous nephrolitotomy
Pediatric PCNL

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Osmaniye Government Hospital

References & Publications (1)

Çitamak B, Altan M, Bozaci AC, Koni A, Dogan HS, Bilen CY, Sahin A, Tekgül 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. over 20 years
Secondary Changing of complications managements Rate of and changing of Management of complications in pediatric patients Over 20 years
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