Emergency Department CT Scanning for Appendicitis

Appendicitis Clinical Trial

Official title:

Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734825
• Other study ID #: 0607012
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: June 27, 2012
• Start date: November 2006
• Est. completion date: September 2010

Study information

• Verified date: June 2012
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency department. A secondary purpose will be to design a specific CT for appendicitis protocol at our institution at the conclusion of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: September 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis

Exclusion Criteria:

• pregnant patients

• patients with known IV dye or oral contrast allergy

• patients in whom acute appendicitis is not the primary diagnosis

• patients with renal insufficiency that may have significant adverse effect from IV dye

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• Omnipaque
oral contrast for CT scan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient.		immediate reading + blinded reading within 48 hours	Yes
Secondary	If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient		immediate reading and blinded reading within 48 hours	Yes