NCT03522233

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

April 18, 2018

Last Update Submit

May 10, 2018

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (2)

  • Rate of Equivocal Appendix Ultrasound

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

    September 2017-October 2018

  • Rate of Appendicitis

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

    September 2017-October 2018

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

Children's Minnesota

Saint Paul, Minnesota, 55102, United States

RECRUITING

Related Publications (12)

  • Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Kene MV, Dehmer SP, Bachur RG, Dayan PS, Kuppermann N, O'Connor PJ, Kharbanda EO. Development and Validation of a Novel Pediatric Appendicitis Risk Calculator (pARC). Pediatrics. 2018 Apr;141(4):e20172699. doi: 10.1542/peds.2017-2699. Epub 2018 Mar 13.

    PMID: 29535251BACKGROUND

  • Pena BM, Taylor GA, Lund DP, Mandl KD. Effect of computed tomography on patient management and costs in children with suspected appendicitis. Pediatrics. 1999 Sep;104(3 Pt 1):440-6. doi: 10.1542/peds.104.3.440.

    PMID: 10469767BACKGROUND

  • Samuel M. Pediatric appendicitis score. J Pediatr Surg. 2002 Jun;37(6):877-81. doi: 10.1053/jpsu.2002.32893.

    PMID: 12037754BACKGROUND

  • Schneider C, Kharbanda A, Bachur R. Evaluating appendicitis scoring systems using a prospective pediatric cohort. Ann Emerg Med. 2007 Jun;49(6):778-84, 784.e1. doi: 10.1016/j.annemergmed.2006.12.016. Epub 2007 Mar 26.

    PMID: 17383771BACKGROUND

  • Ebell MH, Shinholser J. What are the most clinically useful cutoffs for the Alvarado and Pediatric Appendicitis Scores? A systematic review. Ann Emerg Med. 2014 Oct;64(4):365-372.e2. doi: 10.1016/j.annemergmed.2014.02.025. Epub 2014 Apr 14.

    PMID: 24731432BACKGROUND

  • Smith MP, Katz DS, Lalani T, Carucci LR, Cash BD, Kim DH, Piorkowski RJ, Small WC, Spottswood SE, Tulchinsky M, Yaghmai V, Yee J, Rosen MP. ACR Appropriateness Criteria(R) Right Lower Quadrant Pain--Suspected Appendicitis. Ultrasound Q. 2015 Jun;31(2):85-91. doi: 10.1097/RUQ.0000000000000118.

    PMID: 25364964BACKGROUND

  • Howell JM, Eddy OL, Lukens TW, Thiessen ME, Weingart SD, Decker WW; American College of Emergency Physicians. Clinical policy: Critical issues in the evaluation and management of emergency department patients with suspected appendicitis. Ann Emerg Med. 2010 Jan;55(1):71-116. doi: 10.1016/j.annemergmed.2009.10.004.

    PMID: 20116016BACKGROUND

  • Ross MJ, Liu H, Netherton SJ, Eccles R, Chen PW, Boag G, Morrison E, Thompson GC. Outcomes of children with suspected appendicitis and incompletely visualized appendix on ultrasound. Acad Emerg Med. 2014 May;21(5):538-42. doi: 10.1111/acem.12377.

    PMID: 24842505BACKGROUND

  • Pena BM, Taylor GA, Fishman SJ, Mandl KD. Costs and effectiveness of ultrasonography and limited computed tomography for diagnosing appendicitis in children. Pediatrics. 2000 Oct;106(4):672-6. doi: 10.1542/peds.106.4.672.

    PMID: 11015507BACKGROUND

  • Gregory S, Kuntz K, Sainfort F, Kharbanda A. Cost-Effectiveness of Integrating a Clinical Decision Rule and Staged Imaging Protocol for Diagnosis of Appendicitis. Value Health. 2016 Jan;19(1):28-35. doi: 10.1016/j.jval.2015.10.007. Epub 2015 Dec 2.

    PMID: 26797233BACKGROUND

  • Bachur RG, Callahan MJ, Monuteaux MC, Rangel SJ. Integration of ultrasound findings and a clinical score in the diagnostic evaluation of pediatric appendicitis. J Pediatr. 2015 May;166(5):1134-9. doi: 10.1016/j.jpeds.2015.01.034. Epub 2015 Feb 21.

    PMID: 25708690BACKGROUND

  • Partain KN, Patel AU, Travers C, Short HL, Braithwaite K, Loewen J, Heiss KF, Raval MV. Improving ultrasound for appendicitis through standardized reporting of secondary signs. J Pediatr Surg. 2017 Aug;52(8):1273-1279. doi: 10.1016/j.jpedsurg.2016.11.045. Epub 2016 Dec 5.

    PMID: 27939802BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Callie Becker, MD

    Children's Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brianna S McMichael, MPH

CONTACT

612-813-7104Brianna.McMichael@Childrensmn.org

Heidi Vander Velden, MS

CONTACT

(612) 813-7892heidi.vandervelden@childrensmn.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 11, 2018

Study Start

September 23, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2019

Last Updated

May 11, 2018

Record last verified: 2018-04

Locations

US(2)