Status:
COMPLETED
Pediatric KIDney Stone (PKIDS) Care Improvement Network
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Kidney Stone
Nephrolithiasis
Eligibility:
All Genders
8-21 years
Brief Summary
The goals of this study are to improve the ability of pediatric patients and their caregivers to select surgical treatment options for kidney stones and to enable urologists to use techniques that res...
Detailed Description
The rapid increase in the incidence of kidney stones among youth has resulted in a large population of patients who require surgery to removes stones but for whom little evidence exists to guide clini...
Eligibility Criteria
Inclusion
- Males or females, 8-21 years of age, undergoing planned URS, SWL, or PCNL for the removal of at least one kidney and/or ureteral stone.
- Parental/guardian or participant (if ≥ 18 years old) permission (informed consent), and if appropriate, child assent
- 2a. Individuals who are not able to provide consent/assent (whether ≥18 or \< 18 years) and/or not willing or able to complete questionnaires are eligible for participation for the stone clearance assessment and Electronic Health Record (EHR) surveillance if the legal guardian consents for study participation.
- 2b. Individuals for whom native-language questionnaires are not available can also participate in stone clearance assessment and EHR surveillance.
Exclusion
- Patients for whom conducting informed consent and baseline study procedures would confer additional risk (e.g. obstructing ureteral stone with fever requiring emergency surgery) and delay necessary immediate clinical care.
- Parent/guardians or patients, who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Key Trial Info
Start Date :
April 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
1290 Patients enrolled
Trial Details
Trial ID
NCT04285658
Start Date
April 2 2020
End Date
January 31 2024
Last Update
February 20 2024
Active Locations (31)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
UCLA Mattel Children's Hospital
Los Angeles, California, United States, 90095
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045