Pediatric Appendicitis Pathway Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ross Fleischman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01192620
First received: August 30, 2010
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition
Appendicitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pediatric Appendicitis Pathway Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Sensitivity and specificity of criteria [ Time Frame: 2 Weeks after visit ] [ Designated as safety issue: No ]
    Sensitivity and specificity of criteria for diagnosing and excluding appendicitis


Secondary Outcome Measures:
  • Length of stay [ Time Frame: At completion of visit ] [ Designated as safety issue: No ]
    Length of ED length of stay before and after institution of pathway

  • Rates of CT and ultrasound [ Time Frame: After visit ] [ Designated as safety issue: No ]
    Rates of CT and ultrasound use before and after the pathway

  • Admission rate [ Time Frame: After visit ] [ Designated as safety issue: No ]
    Admission rate before and after institution of pathway


Estimated Enrollment: 2000
Study Start Date: October 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • Chief complaint of acute appendicitis

Exclusion Criteria:

  • Patients with symptoms greater than 7 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192620

Contacts
Contact: Ross J Fleischman, MD, MCR 503-494-7551 fleischr@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science Univerisity Recruiting
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Ross J Fleischman, MD, MCR Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Ross Fleischman, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01192620     History of Changes
Other Study ID Numbers: IRB00006596
Study First Received: August 30, 2010
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Pediatric Appendicitis
Pathway

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014