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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Appendicitis

Treatments: Radiation: Diagnostic CT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00913380

SNUBH-LDCTinAPPY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 891 patients

Sex: All

Ages: 15 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected of having acute appendicitis
• Referred for abdomen CT from Emergency Department

Exclusion criteria

• Body mass index < 18.5 kg/m2 (ultrasonography is favored)
• Intravenous contrast-enhancement is contraindicated

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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891 participants in 2 patient groups

Low-dose CT

Experimental group

Treatment:

Radiation: Diagnostic CT

Radiation: Diagnostic CT

Standard-dose CT

Active Comparator group

Treatment:

Radiation: Diagnostic CT

Radiation: Diagnostic CT