CT Scan Using IV Contrast Alone for Pediatric Appendicitis

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00716703
First received: July 14, 2008
Last updated: July 15, 2008
Last verified: July 2008
  Purpose

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.

Condition Intervention
Appendicitis
Child
Contrast Media
Other: CT Scan using IV contrast alone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone [ Time Frame: Study completion date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast [ Time Frame: study completion date ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: November 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT00716703

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Madelyn Garcia, MD, MPH University of Rochester
Principal Investigator: Lynn Babcock-Cimpello, MD University of Rochester
  More Information

No publications provided

Responsible Party: Madelyn Garcia, MD, MPH, University of Rochester, Dept of Emergency Medicine
ClinicalTrials.gov Identifier: NCT00716703     History of Changes
Other Study ID Numbers: RSRB9986
Study First Received: July 14, 2008
Last Updated: July 15, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Appendicitis
Computed tomography
pediatric
child
sensitivity
specificity
contrast administration route
time factors

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 September 22, 2014