NCT00913380

Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT

Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 891 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.

Detailed description

Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is an established first-line diagnostic test in patients suspected of having acute appendicitis. Since many individuals suspected of having acute appendicitis are young, with a mean age of 30 years, CT radiation is of particular concern. The estimated lifetime attributable risk of death from cancer due to the radiation exposure of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age. The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the negative appendectomy rate.

Conditions

• Appendicitis

Interventions

Type	Name	Description
RADIATION	Diagnostic CT	2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
RADIATION	Diagnostic CT	8 mSv in an average patient (Standard-dose CT)

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-06-04
• Last updated: 2011-09-12
• Results posted: 2011-09-02

Locations

1 site across 1 country: South Korea