We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pediatric Appendicitis Pathway Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Ross Fleischman, Oregon Health and Science University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192620
First Posted: September 1, 2010
Last Update Posted: May 2, 2012
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.
Information provided by (Responsible Party):
Ross Fleischman, Oregon Health and Science University
  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 Ross Fleischman, Oregon Health and Science University:

Primary Outcome Measures:
  • Sensitivity and specificity of criteria [ Time Frame: 2 Weeks after visit ]
    Sensitivity and specificity of criteria for diagnosing and excluding appendicitis


Secondary Outcome Measures:
  • Length of stay [ Time Frame: At completion of visit ]
    Length of ED length of stay before and after institution of pathway

  • Rates of CT and ultrasound [ Time Frame: After visit ]
    Rates of CT and ultrasound use before and after the pathway

  • Admission rate [ Time Frame: After visit ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Ross Fleischman, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01192620     History of Changes
Other Study ID Numbers: IRB00006596
First Submitted: August 30, 2010
First Posted: September 1, 2010
Last Update Posted: May 2, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases