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

October 29, 2020 updated by: Stefania Ferretti, Azienda Ospedaliero-Universitaria di Parma
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43125
        • AOU Parma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

0-17 yrs old, urinary stones (kidney, ureteral, not bladder), with or without malformations or metabolic diseases

Description

Inclusion Criteria:

  • 0-17 yrs old, urinary stones (kidney, ureteral, not bladder), with or without malformations or metabolic diseases

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone free rate
Time Frame: immediately
no stones or residual fragment < 4 mm
immediately
stone free rate
Time Frame: 3 months follow up
no stones or residual fragment < 4 mm
3 months follow up
complication rate
Time Frame: immediately
clavien-dindo classification
immediately
complication rate
Time Frame: 3 months follow up
clavien-dindo classification
3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 490/2019/OSS*/AOUPR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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