The Success of Pediatric Percutaneous Nephrolithotomy

NCT04299204 | Completed

• 1 other identifier: OsmaniyeGH
• Study Type: interventional
• Target: 553
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nephrolithiasis

Keywords

Urolithiasis; Pediatrics; Percutaneous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changing of complications managements

  Over 20 years

Study Arms (2)

Years 1997-2007

EXPERIMENTAL

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

Procedure: Percutaneous nephrolitotomy

2008- to the present

EXPERIMENTAL

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

Procedure: Percutaneous nephrolitotomy

Interventions

Percutaneous nephrolitotomy PROCEDURE

Pediatric PCNL

2008- to the present; Years 1997-2007

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients with kidney stone

You may not qualify if:

• Patients with a solitary kidney

Sponsors & Collaborators

• Osmaniye Government Hospital: lead

Related Publications (1)

• 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.

  PMID: 26682755 RESULT

MeSH Terms

Conditions

Nephrolithiasis; Urolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 6, 2020
• Study Start: January 15, 1998
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 6, 2020

Record last verified: 2020-03