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

Phase 3

Completed

• Conditions: Appendicitis
• Interventions: Radiation: Diagnostic CT

• Registration Number: NCT00913380
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Study Start: 2009-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2011-06-27
• Results First Submitted QC: 2011-08-02
• Status Verified: 2011-09
• Results First Posted: 2011-09-02
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 891

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose CT	Diagnostic CT	-
Standard-dose CT	Diagnostic CT	-

Primary Outcome Measures

Name	Time	Method
Negative Appendectomy	1 week after surgery	Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)

Secondary Outcome Measures

Name	Time	Method
Additional Imaging Test(s)	1 week after CT	Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis
Appendiceal Perforation	1 week after surgery	Number of participants with appendiceal perforation
Interval Between CT and Appendectomy	1 day after surgery	Time interval between the CT acquisition and non-incidental appendectomy
Interval Between CT and Discharge Without Surgery	3 months after CT	Time interval between the CT acquisition and discharge without surgery
Interval From CT to Discharge After Appendectomy	3 months after CT	Time interval between the CT acquisition and discharge after appendectomy
Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis	3 months after CT	Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.; Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence.
Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis	3 months after CT	Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.; Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence.
Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.	3 months after CT	True positive: Perforation was rated as present in CT report and confirmed as present.; False positive: Perforation was rated as present in CT report and confirmed as absent.; True negative: Perforation was rated as absent in CT report and confirmed as absent.; False negative: Perforation was rated as absent in CT report and confirmed as present.; The data are used to calculate sensitivity and specificity.
Visualization of the Normal Appendix	3 months after CT	Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of