Quality of Life for Pediatric Urolithiasis (Elattar)

October 15, 2023 updated by: Ahmed R. EL-Nahas, Mansoura University

Assessment of Health-Related Quality of Life for Pediatric Patients With Urinary Stone Disease.

The aim of this study is to assess the quality of life (QoL) in pediatric patients with urinary stone disease.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study will assess the quality of life (QoL) in pediatric patients with urinary stone disease using the pediatric quality of life (PedsQol) questionnaire in comparison to normal healthy age/sex matched population.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Recruiting
        • Urology and nephrology center
        • Contact:
          • M
        • Contact:

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All pediatric patients with urolithiasis.

Description

Inclusion Criteria:

  • Patients who had urinary stones

Exclusion Criteria:

  1. Patients presenting with obstructive uropathy or urosepsis.
  2. Recent (less than 4 weeks) surgical intervention for urinary stone disease.
  3. Indwelling urinary catheters or stents (urethral catheter, ureteral stents or nephrostomy tube).
  4. Associated mental illness or cognitive dysfunction.
  5. Associated chronic medical illness that may compromise QoL.

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

Cohorts and Interventions

Group / Cohort
Patients
Pediatric patients who underwent treatment for utrollithiasis.
Control
Cross-matched group of healthy children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The PedsQL questionnaire
Time Frame: 12 months
comparison of overall PedsQL score between pediatric urolithiasis patients and normal healthy age/sex matched population.
12 months

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ahmed R EL-Nahas, MD, Mansoura University

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)

February 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 15, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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