CT Dose Simulation Study for Appendicitis

Seoul National University

Status: Completed

Conditions: Appendicitis

Treatments: Radiation: CT

Study type: Observational

Funder types: Other

Identifiers

NCT02556983

SNUBH-02-2015-030

Details and patient eligibility

About

The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction.

Full description

Three sequential non-inferiority tests are planned. First, three readers will review the original 2-mSv images. Second, the readers will review the 75%-dose images. After the readers review the 75%-dose images and before the readers reviewed the 50%-dose images, the non-inferiority of 75% dose to the original dose will be tested. If the non-inferiority is not accepted, the study will be terminated with the conclusion of 2 mSv as the lowest acceptable dose. If the non-inferiority is accepted, the study will be continue to the next step. In the same manner, the readers will review the next lower-dose images (50% and then 25%), and then the noninferiority will be tested against the original dose.

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-44 years of age.
• Emergency department visit with suspected symptoms and signs of acute appendicitis
• Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis

Exclusion criteria

• having contraindications of intravenous contrast agent

Trial design

30 participants in 1 patient group

Suspected appendicitis

Description:

Patients who are suspected as having acute appendicitis

Treatment:

Radiation: CT