Pediatric KIDney Stone (PKIDS) Care Improvement Network
- Conditions
- Kidney StoneNephrolithiasis
- Interventions
- Procedure: Percutaneous NephrolithotomyProcedure: UreteroscopyProcedure: Shock Wave Lithotripsy
- Registration Number
- NCT04285658
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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 result in the best outcomes for these surgeries.
- 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 clinical care. Proper selection of surgical treatment options, which is directed by patient-specific factors and individual treatment goals, is the greatest determinant of successful outcomes.
This is a prospective cohort study. Investigators seek to compare stone clearance, re-treatment, and unplanned healthcare encounters for ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy.
Additionally, Investigators also seek to compare patients' experiences after ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy.
Setting/Participants:
This study will be conducted by the Pediatric KIDney Stone (PKIDS) Care Improvement Network, which includes 23 pediatric healthcare systems (25 sites) in the United States.
Patient participants include patients aged 8 to 21 years who undergo a surgical intervention for kidney stones as part of their clinical care. The surgical interventions include ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy, all of which would be performed as part of routine clinical care.
Study Interventions and Measures:
Stone clearance will be assessed with ultrasound (obtained as part of clinical care) 6 weeks after surgery, which is the standard of care at all PKIDS sites. Re-treatment and unplanned healthcare encounters will be assessed within the first 3 months after surgery. Patients' experiences will be measured through questionnaires administered pre-operatively and within 3 months after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1290
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy - Ureteroscopy Ureteroscopy - Shock Wave Lithotripsy Shock Wave Lithotripsy -
- Primary Outcome Measures
Name Time Method Stone clearance 6 weeks post-op +/- 2 weeks Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound.
- Secondary Outcome Measures
Name Time Method Patient-Reported Outcomes Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery Patients' experiences before and after URS, SWL, and PCNL will be measured. Investigators will assess the immediate and delayed impact of surgery on patient-reported outcomes (PROs) selected by PKIDS patient partners. The patient reported outcomes (PROs) include the Patient-Reported Outcomes Measurement Information System (PROMIS), other questionnaires commonly used in studying the impact of kidney stone disease on health states, and urinary tract symptoms.
Patients' Experiences Up to 90 days after surgery Investigators will also determine unplanned hospitalizations, emergency department (ED) visits, and repeat surgeries for the 3 months following each procedure to examine impact on patients' experiences.
Trial Locations
- Locations (31)
UCLA Mattel Children's Hospital
🇺🇸Los Angeles, California, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Nemours A. I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Health System
🇺🇸Washington, District of Columbia, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Richmond at VCU
🇺🇸Richmond, Virginia, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of Florida Health Shands Children's Hospital
🇺🇸Gainesville, Florida, United States
Nemours Children's Specialty Care
🇺🇸Jacksonville, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
Cohen Children's Medical Center
🇺🇸New York, New York, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Children's Wisconsin
🇺🇸Milwaukee, Wisconsin, United States