Pediatric KIDney Stone (PKIDS) Care Improvement Network
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,290
- 试验地点
- 31
- 主要终点
- Stone clearance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Stone clearance
时间窗: 6 weeks post-op +/- 2 weeks
Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound.
次要结局
- Patient-Reported Outcomes(Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery)
- Patients' Experiences(Up to 90 days after surgery)