CT Scan Using IV Contrast Alone for Pediatric Appendicitis

July 15, 2008 updated by: University of Rochester

Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast material, was studied as one method of evaluating children with suspected appendicitis. We felt that this technique could provide physicians with a faster and better-tolerated alternative to CT imaging which involves patients drinking oral contrast or needing rectal contrast administered.

SPECIFIC AIMS

  1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in children in the setting of a pediatric emergency department (ED).
  2. To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was to be a prospective cohort study imaging pediatric patients (3-18 years old) in whom the diagnosis of appendicitis was suspected, but not clinically apparent. Patients that were to have a CT performed would be invited to participate and if enrolled, would be imaged using CT scan with IV contrast alone.

CT scans would be interpreted in real time by a resident radiologist and/or an attending radiologist. ED evaluation would remain unchanged and patient disposition would be based on the discretion of the ED provider using all information (patient exam, labs, surgical consultation as needed and the results of the CT scan).

CT scan performance would be determined by comparison of the CT interpretation with patient final outcomes as determined by either (1) pathology reports - in patients that went on to have surgery (appendectomy) or (2) clinical phone follow up at 24 hrs and then 1 week after ED discharge.

Performance of CT would be compared between the resident and the attending radiologists.

Further, we would compare the time to obtain a CT scan (defined as ED triage time - Time to CT) between our study cohort and a retrospective cohort of patients who had received CT scan in the ED for evaluation of appendicitis pre-study (CT using BOTH IV and oral contrast).

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 3- 18 years
  • Signs/symptoms for < 72 hours
  • CT Scan requested for evaluation by attending or fellow

Exclusion Criteria:

  • Clinically apparent appendicitis
  • Pregnancy
  • Sickle Cell Disease
  • Known contrast allergy
  • Previous enrollment
  • Signs/symptoms for > 72 hrs
  • Known abdominal disease (e.g. Crohn's)
  • Exam unreliable (neurologically impaired patient)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan
Other: CT Scan using IV contrast alone
CT scan using IV contrast alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone
Time Frame: Study completion date
Study completion date

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast
Time Frame: study completion date
study completion date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Madelyn Garcia, MD, MPH, University of Rochester
  • Principal Investigator: Lynn Babcock-Cimpello, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (ACTUAL)

October 1, 2005

Study Completion (ACTUAL)

October 1, 2005

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (ESTIMATE)

July 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2008

Last Update Submitted That Met QC Criteria

July 15, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB9986

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe