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

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Diagnostic CT
Diagnostic CT
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis

Eligibility Criteria

15 Years - 44 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-dose CT

Standard-dose CT

Arm Description

Outcomes

Primary Outcome Measures

Negative Appendectomy
Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)

Secondary Outcome Measures

Additional Imaging Test(s)
Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis
Appendiceal Perforation
Number of participants with appendiceal perforation
Interval Between CT and Appendectomy
Time interval between the CT acquisition and non-incidental appendectomy
Interval Between CT and Discharge Without Surgery
Time interval between the CT acquisition and discharge without surgery
Interval From CT to Discharge After Appendectomy
Time interval between the CT acquisition and discharge after appendectomy
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.
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.
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.
Visualization of the Normal Appendix
Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized

Full Information

First Posted
May 15, 2009
Last Updated
September 2, 2011
Sponsor
Seoul National University Bundang Hospital
Collaborators
GE Healthcare, National Research Foundation of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00913380
Brief Title
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
Official Title
Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
GE Healthcare, National Research Foundation of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
891 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose CT
Arm Type
Experimental
Arm Title
Standard-dose CT
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Diagnostic CT
Other Intervention Name(s)
low-dose CT
Intervention Description
2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
Intervention Type
Radiation
Intervention Name(s)
Diagnostic CT
Other Intervention Name(s)
standard-dose CT
Intervention Description
8 mSv in an average patient (Standard-dose CT)
Primary Outcome Measure Information:
Title
Negative Appendectomy
Description
Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
Additional Imaging Test(s)
Description
Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis
Time Frame
1 week after CT
Title
Appendiceal Perforation
Description
Number of participants with appendiceal perforation
Time Frame
1 week after surgery
Title
Interval Between CT and Appendectomy
Description
Time interval between the CT acquisition and non-incidental appendectomy
Time Frame
1 day after surgery
Title
Interval Between CT and Discharge Without Surgery
Description
Time interval between the CT acquisition and discharge without surgery
Time Frame
3 months after CT
Title
Interval From CT to Discharge After Appendectomy
Description
Time interval between the CT acquisition and discharge after appendectomy
Time Frame
3 months after CT
Title
Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis
Description
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.
Time Frame
3 months after CT
Title
Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis
Description
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.
Time Frame
3 months after CT
Title
Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.
Description
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.
Time Frame
3 months after CT
Title
Visualization of the Normal Appendix
Description
Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized
Time Frame
3 months after CT
Other Pre-specified Outcome Measures:
Title
Radiation Dose
Description
Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The "length" indicates the scan range.
Time Frame
1 day after CT
Title
Estimate of Carcinogenic Risk Induced by CT Radiation
Description
Age- and sex-specific carcinogenic risk induced by CT radiation. This is not an actual measurement but an estimate of the stochastic risk, based on assumption and calculation from radiation dose used.
Time Frame
1 day after CT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoung Ho Lee, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22533576
Citation
Kim K, Kim YH, Kim SY, Kim S, Lee YJ, Kim KP, Lee HS, Ahn S, Kim T, Hwang SS, Song KJ, Kang SB, Kim DW, Park SH, Lee KH. Low-dose abdominal CT for evaluating suspected appendicitis. N Engl J Med. 2012 Apr 26;366(17):1596-605. doi: 10.1056/NEJMoa1110734.
Results Reference
derived

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

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