NCT01192620

Brief Summary

The purpose of this study is to test a standardized approach for children being evaluated for appendicitis in the emergency department. This means that all doctors would use the same approach to diagnose appendicitis in children in the emergency department. This pathway uses two scoring systems to identify patients who are at high and low risks of appendicitis. These scoring systems are based on the patient's symptoms, signs the doctor finds when examining the patient, and their blood tests. The goal of this part of the study is to determine if the investigators' pathway accurately identifies patients who have appendicitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2011

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

August 30, 2010

Last Update Submit

April 8, 2019

Conditions

Keywords

Pediatric AppendicitisPathway

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of criteria

    Sensitivity and specificity of criteria for diagnosing and excluding appendicitis

    2 Weeks after visit

Secondary Outcomes (3)

  • Length of stay

    At completion of visit

  • Rates of CT and ultrasound

    After visit

  • Admission rate

    After visit

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A consecutive sample of all patients ages 3 through 18 presenting to the Oregon Health and Science University (OHSU) emergency department (ED) for suspicion of appendicitis during the hours in which study staff are available will be prospectively enrolled.

You may qualify if:

  • Chief complaint of acute appendicitis

You may not qualify if:

  • Patients with symptoms greater than 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science Univerisity

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Ross J Fleischman, MD, MCR

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 1, 2010

Study Start

October 1, 2010

Primary Completion

August 31, 2011

Study Completion

August 31, 2011

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations