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Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522233
Recruitment Status : Unknown
Verified April 2018 by Children's Hospitals and Clinics of Minnesota.
Recruitment status was:  Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

Brief Summary:
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.

Condition or disease
Appendicitis

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes and Charges After Risk Stratification by Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds at a Tertiary Care Pediatric Hospital
Actual Study Start Date : September 23, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of Equivocal Appendix Ultrasound [ Time Frame: September 2017-October 2018 ]
    To determine the rate of equivocal appendix US among children with pARC <25%.

  2. Rate of Appendicitis [ Time Frame: September 2017-October 2018 ]
    To determine rate of appendicitis among children with pARC <25% who had an appendix ultrasound.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will collect data on all patients presenting to the emergency departments of Children's Minnesota between the ages of 5-18 years old who have a US of the appendix performed in the ED over 12 month period from September 23, 2017 to October 1, 2018.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522233


Contacts
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Contact: Brianna S McMichael, MPH 612-813-7104 Brianna.McMichael@Childrensmn.org
Contact: Heidi Vander Velden, MS (612) 813-7892 heidi.vandervelden@childrensmn.org

Locations
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United States, Minnesota
Children's Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Brianna McMichael, MPH         
Children's Minnesota Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Brianna McMichael, MPH         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
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Principal Investigator: Callie Becker, MD Children's Minnesota
Publications:

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Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT03522233    
Other Study ID Numbers: 1708-113
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases