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

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913380
• Other study ID #: SNUBH-LDCTinAPPY
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2009
• Last updated: September 2, 2011
• Start date: September 2009
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 891
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Appendicitis

Intervention

Radiation:
• Diagnostic CT
2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
• Diagnostic CT
8 mSv in an average patient (Standard-dose CT)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	GE Healthcare, National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative Appendectomy	Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)	1 week after surgery	No
Secondary	Additional Imaging Test(s)	Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis	1 week after CT	No
Secondary	Appendiceal Perforation	Number of participants with appendiceal perforation	1 week after surgery	Yes
Secondary	Interval Between CT and Appendectomy	Time interval between the CT acquisition and non-incidental appendectomy	1 day after surgery	No
Secondary	Interval Between CT and Discharge Without Surgery	Time interval between the CT acquisition and discharge without surgery	3 months after CT	No
Secondary	Interval From CT to Discharge After Appendectomy	Time interval between the CT acquisition and discharge after appendectomy	3 months after CT	Yes
Secondary	Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis	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.	3 months after CT	No
Secondary	Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis	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.	3 months after CT	No
Secondary	Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.	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.	3 months after CT	No
Secondary	Visualization of the Normal Appendix	Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized	3 months after CT	No