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Clinical Trials/NCT04299204
NCT04299204CompletedNot Applicable

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

Osmaniye Government Hospital0 sites553 target enrollmentStarted: January 15, 1998Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
553
Primary Endpoint
Safety and Efficacy of clinical experience of Percutaneous nephrolitotomy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
1 Year to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pediatric patients with kidney stone

Exclusion Criteria

  • •Patients with a solitary kidney

Arms & Interventions

Years 1997-2007

Experimental

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

Intervention: Percutaneous nephrolitotomy (Procedure)

2008- to the present

Experimental

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

Intervention: Percutaneous nephrolitotomy (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changing of complications managements(Over 20 years)

Investigators

Sponsor
Osmaniye Government Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

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