NCT01925014

Low vs. Standard Dose CT for Appendicitis Trial

A Multi-institutional Trial Comparing Clinical Outcomes Following Low- vs. Standard-dose Abdominal CT as the First-line Imaging Test in Adolescents and Young Adults With Suspected Acute Appendicitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,074 (actual)
• Sponsor: Kyoung Ho Lee, MD · Academic / Other
• Sex: All
• Age: 15 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).

Detailed description

* Acute appendicitis is a very common disease. Many patients are adolescents or young adults. * CT is the current standard imaging test for the diagnosis of appendicitis. * In recent years, the awareness of carcinogenic risk associated with CT radiation has increased. * According to a recent single-institutional randomized controlled trial, LD CT (employing a quarter of standard radiation dose) was found to be noninferior to SD CT with respect to NARs in adolescents and young adults with suspected appendicitis. * However, LD CT is not yet widely accepted. * To establish LD CT as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.

Conditions

• Appendicitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic CT with low-dose radiation	Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.
DIAGNOSTIC_TEST	Diagnostic CT with standard-dose radiation	Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2013-08-19
• Last updated: 2019-01-31
• Results posted: 2019-01-31

Locations

20 sites across 1 country: South Korea