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NCT04605315 Clinical Trial

Indications and Outcomes in Kidney-ureteral Pediatric Lithiasis: Experience of Parma

Pediatric ALL Clinical Trial

Official title:
Indications and Outcomes in Kidney-ureteral Pediatric Lithiasis: Experience of Parma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04605315
Other study ID # 490/2019/OSS*/AOUPR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date August 31, 2019

Study information
Verified date October 2020
Source Azienda Ospedaliero-Universitaria di Parma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Incidence of paediatric urolithiasis is increasing in Europe and North America. Nowadays the management of stone disease is a common practice in not endemic country. The surgical's treatment is based on similar techniques as for adults. In the last years due to miniaturization of endoscopic instruments endourology has become the best approach to treat urinary stones in children. The investigators have retrospectively reviewed experience from 01/01/2000 to 28/02/2019 in children ≤ 16 years old affected by urinary stones who underwent rigid and flexible ureterorenoscopy and pecutaneous nephrolitotripsy procedures and recorded clinical data, overall success rate and complication.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - 0-17 yrs old, urinary stones (kidney, ureteral, not bladder), with or without malformations or metabolic diseases Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy AOU Parma Parma

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria di Parma

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary stone free rate no stones or residual fragment < 4 mm immediately
Primary stone free rate no stones or residual fragment < 4 mm 3 months follow up
Primary complication rate clavien-dindo classification immediately
Primary complication rate clavien-dindo classification 3 months follow up
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