CT Scan Using IV Contrast Alone for Pediatric Appendicitis

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: Child; Appendicitis; Contrast Media
• Intervention / Treatment: Other: CT Scan using IV contrast alone

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	study completion date

Collaborators and Investigators

• 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

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: pediatric; Computed tomography; child; Appendicitis; sensitivity; specificity; contrast administration route; time factors
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: RSRB9986