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CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Primary Purpose

Appendicitis, Child, Contrast Media

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT Scan using IV contrast alone
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis focused on measuring Appendicitis, Computed tomography, pediatric, child, sensitivity, specificity, contrast administration route, time factors

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan

Outcomes

Primary Outcome Measures

Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone

Secondary Outcome Measures

Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast

Full Information

First Posted
July 14, 2008
Last Updated
July 15, 2008
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00716703
Brief Title
CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Official Title
CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 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). To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Child, Contrast Media
Keywords
Appendicitis, Computed tomography, pediatric, child, sensitivity, specificity, contrast administration route, time factors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan
Intervention Type
Other
Intervention Name(s)
CT Scan using IV contrast alone
Intervention Description
CT scan using IV contrast alone
Primary Outcome Measure Information:
Title
Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone
Time Frame
Study completion date
Secondary Outcome Measure Information:
Title
Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast
Time Frame
study completion date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madelyn Garcia, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynn Babcock-Cimpello, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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CT Scan Using IV Contrast Alone for Pediatric Appendicitis

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