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The Success of Pediatric Percutaneous Nephrolithotomy

Primary Purpose

Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous nephrolitotomy
Sponsored by
Osmaniye Government Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring Urolithiasis, Pediatrics, Percutaneous

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric patients with kidney stone

Exclusion Criteria:

  • Patients with a solitary kidney

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Years 1997-2007

    2008- to the present

    Arm Description

    Group-1, PCNL was performed in the first 10 years period (Years 1997-2007);

    The PCNL was performed in the second ten years period from 2008 to the present.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Changing of complications managements
    Rate of and changing of Management of complications in pediatric patients

    Full Information

    First Posted
    March 2, 2020
    Last Updated
    March 4, 2020
    Sponsor
    Osmaniye Government Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04299204
    Brief Title
    The Success of Pediatric Percutaneous Nephrolithotomy
    Official Title
    Which Factor Affect the Success of Pediatric PCNL?: Single Center Experiences, Over 20 Years: Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 1998 (Actual)
    Primary Completion Date
    June 1, 2018 (Actual)
    Study Completion Date
    July 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Osmaniye Government Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nephrolithiasis
    Keywords
    Urolithiasis, Pediatrics, Percutaneous

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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
    Participant
    Allocation
    Non-Randomized
    Enrollment
    553 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Years 1997-2007
    Arm Type
    Experimental
    Arm Description
    Group-1, PCNL was performed in the first 10 years period (Years 1997-2007);
    Arm Title
    2008- to the present
    Arm Type
    Experimental
    Arm Description
    The PCNL was performed in the second ten years period from 2008 to the present.
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous nephrolitotomy
    Intervention Description
    Pediatric PCNL
    Primary Outcome Measure Information:
    Title
    Safety and Efficacy of clinical experience of Percutaneous nephrolitotomy
    Description
    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.
    Time Frame
    over 20 years
    Secondary Outcome Measure Information:
    Title
    Changing of complications managements
    Description
    Rate of and changing of Management of complications in pediatric patients
    Time Frame
    Over 20 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pediatric patients with kidney stone Exclusion Criteria: Patients with a solitary kidney

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The data belonged to Cukurova University, Department of Urology
    Citations:
    PubMed Identifier
    26682755
    Citation
    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.
    Results Reference
    result

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    The Success of Pediatric Percutaneous Nephrolithotomy

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