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临床试验/NCT03522233
NCT03522233Unknown不适用

Clinical Outcomes and Charges After Risk Stratification by Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds at a Tertiary Care Pediatric Hospital

Children's Hospitals and Clinics of Minnesota1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2017年9月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
800
试验地点
1
主要终点
Rate of Equivocal Appendix Ultrasound

研究概览

简要总结

Acute appendicitis (AA) is the most common condition requiring emergency surgery in children. At a network of institutions nationwide, a tool called the pediatric appendicitis risk calculator (pARC)1 is being studied to assess patient's true risk of appendicitis and provide guidance for clinical management to ER physicians. Preliminary studies have found the pARC to be more accurate at predicting risk of appendicitis in children when compared to other scoring systems. The study objective is to assess acute care charges and clinical outcomes among children with an appendix ultrasound and a pARC score of less than < 25% risk.

详细描述

Background Acute appendicitis (AA) is the most common condition requiring emergency surgery in children. The potential for morbidity and mortality from perforation of the appendix necessitates prompt diagnosis.2 Acute appendicitis scoring systems such as pediatric appendicitis score (PAS) use elements of history, exam findings, and lab tests to identify patients at high risk of having acute appendicitis.3 Despite having limited use for this intent 4,5 these scores are often used to stratify patients by risk for continued observation, imaging or operative care. 6 While CT scans may have higher diagnostic yield, its use is not without risk. CT- related radiation exposure has been shown to increase cancer risk. There have been US first strategies published by the American College of Radiology7 and the American College of Emergency Physicians.8 However, nearly 50% of appendix US examinations are equivocal, which poses a dilemma for EM physicians and results in variation in clinical care.

Various strategies exist for the diagnostic approach to the patient after equivocal US with symptoms of AA. While select patients may be safely discharged based on clinical judgment,9 emergency providers often obtain CT or admit patients for clinical observation. In a study conducted by Garcia et al., they concluded that a protocol of US followed by CT in children with negative or equivocal US exam results in beneficial management as well as cost savings.10 In a study by Gregory et al., they concluded that a clinical decision rule followed by staged imaging was found to be the most cost-effective approach for diagnosis of AA in children.11 Bachur et al. integrated PAS score with US findings and concluded that patients with high risk (PAS 7-10) but negative US or low risk (PAS 0-3) benefit from serial exam or further work up. 12 The addition of US to the strategy reduced CT utilization.11 Standardized radiology reports have also been shown to reduce CT scans and admissions for observation.13 At a network of institutions nationwide a tool called the pediatric appendicitis risk calculator (pARC)1 is being studied to assess patient's true risk of appendicitis and provide guidance for clinical management to ER physicians. Preliminary studies have found the pARC to be more accurate at predicting risk of appendicitis in children when compared to PAS score.

The study objective is to assess acute care charges and clinical outcomes among children with appendix US and pARC < 25%. To the investigator's knowledge, this is the first study to do so in a tertiary care pediatric hospital.

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
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 5-18 years
  • Patients who had an appendix ultrasound in one of our EDs

排除标准

  • Outside appendix ultrasound or abdominal CT obtained
  • Previous significant abdominal surgery (for example appendectomy, short gut, ileostomy, Hirschsprungs with pull through)
  • No CBC obtained (i.e. cannot determine pARC)
  • Developmental or cognitive delay that impedes communication
  • If there is suspected abuse

结局指标

主要结局

Rate of Equivocal Appendix Ultrasound

时间窗: September 2017-October 2018

To determine the rate of equivocal appendix US among children with pARC \<25%.

Rate of Appendicitis

时间窗: September 2017-October 2018

To determine rate of appendicitis among children with pARC \<25% who had an appendix ultrasound.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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