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OpenTrials
Completed

NCT Number: NCT00716703

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.

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CT Scan using IV contrast alone

Other

CT scan using IV contrast alone

Primary outcomes

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

    Time frame: Study completion date

Secondary outcomes

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

    Time frame: study completion date

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jul 16, 2008
Registry last updated
Jul 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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