Pediatric KIDney Stone (PKIDS) Care Improvement Network

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pediatric KIDney Stone (PKIDS) Care Improvement Network

Conditions
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Kidney Stone, Nephrolithiasis

Intervention / Treatment
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* Procedure: Ureteroscopy
* Procedure: Percutaneous Nephrolithotomy
* Procedure: Shock Wave Lithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ureteroscopy<br> | Procedure: Ureteroscopy<br>* An outpatient endoscopic surgery that accesses the ureters and kidneys per the urethra to fragment and remove the stones. Many patients who undergo ureteroscopy (URS), Shockwave lithotripsy (SWL), or percutaneous nephrolithotomy (PCNL) also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).<br>* Other names: URS;|
| Percutaneous Nephrolithotomy<br> | Procedure: Percutaneous Nephrolithotomy<br>* A minimally invasive surgery in which a  1cm flank incision is made, and a scope is passed through a tubular sheath into the kidney to fragment and remove the stone. There is typically a 1- to 2-day hospital stay. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).<br>* Other names: PCNL;|
| Shock Wave Lithotripsy<br> | Procedure: Shock Wave Lithotripsy<br>* A non-invasive outpatient procedure that targets stones in the kidney or ureter with x-ray or ultrasound and uses shockwaves generated outside the body to fragment them; the fragments pass down the ureter and the patient expels them in the urine. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).<br>* Other names: SWL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone clearance | Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound. | 6 weeks post-op +/- 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes | 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. | Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery | 
| Patients' Experiences | Investigators will examine Heterogeneity of Treatment Effect (HTE) by age and sex and identify modifiable surgical techniques that impact patient experiences for each surgery. | Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery | 
| Patients' Experiences | 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. | Up to 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney, kidney stone, nephrolithiasis, Comparative Effectiveness, Patient Reported Outcomes