NCT04605315

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

September 30, 2020

Last Update Submit

October 29, 2020

Conditions

Pediatric ALLStone, Urinary

Outcome Measures

Primary Outcomes (4)

  • stone free rate

    no stones or residual fragment \< 4 mm

    immediately

  • stone free rate

    no stones or residual fragment \< 4 mm

    3 months follow up

  • complication rate

    clavien-dindo classification

    immediately

  • complication rate

    clavien-dindo classification

    3 months follow up

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Parma

Parma, 43125, Italy

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaUrinary Calculi

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesUrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of endourology-OU Urology

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 28, 2020

Study Start

July 1, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

IT(1)