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

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ClinicalTrials.gov Identifier: NCT00913380
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : September 2, 2011
Last Update Posted : September 12, 2011
Sponsor:
Collaborators:
GE Healthcare
National Research Foundation of Korea
Information provided by (Responsible Party):
Kyoung Ho Lee, Seoul National University Bundang Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Condition Appendicitis
Intervention Radiation: Diagnostic CT
Enrollment 891
Recruitment Details Dates of the recruitment period: September 2009 to January 2011 Types of location: an emergency department in an urban tertiary hospital in Korea
Pre-assignment Details None of the enrolled participants were excluded from the trial before assignment to group.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description Aimed to 2 mSv in an average patient Aimed to 8 mSv in an average patient
Period Title: CT Examination
Started 444 447
Completed 444 447
Not Completed 0 0
Period Title: Clinical Outcomes
Started 444 447
Completed 438 441
Not Completed 6 6
Reason Not Completed
Lost to Follow-up             6             6
Arm/Group Title Low-dose CT Standard-dose CT Total
Hide Arm/Group Description Aimed to 2 mSv in an average patient Aimed to 8 mSv in an average patient Total of all reporting groups
Overall Number of Baseline Participants 444 447 891
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Year
Age (year) Number Analyzed 444 participants 447 participants 891 participants
29
(21.5 to 36)
30
(22 to 37)
30
(22 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 447 participants 891 participants
Female
276
  62.2%
263
  58.8%
539
  60.5%
Male
168
  37.8%
184
  41.2%
352
  39.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 444 participants 447 participants 891 participants
Korean 441 445 886
Non-Korean 3 2 5
Body mass index  
Measure Type: Number
Unit of measure:  Kg/m^2
Number Analyzed 444 participants 447 participants 891 participants
< 18.5 (underweight) 62 60 122
18.5-24.9 (normal) 312 301 613
≥ 25.0 (overweight to extremely obese) 70 86 156
White blood cell  
Median (Inter-Quartile Range)
Unit of measure:  X10^3/mm^3
Number Analyzed 444 participants 447 participants 891 participants
10.7
(7.8 to 14.1)
10.8
(8.0 to 14.3)
10.8
(7.9 to 14.2)
Segmented neutrophil  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of peripheral Leukocytes
Number Analyzed 444 participants 447 participants 891 participants
77.0
(65.8 to 85.2)
77.3
(65.5 to 83.9)
77.3
(65.7 to 84.6)
C-reactive protein  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 444 participants 447 participants 891 participants
0.5
(0.3 to 2.5)
0.7
(0.3 to 3.3)
0.6
(0.3 to 3.1)
CT scanner  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 444 participants 447 participants 891 participants
16-detector CT 177 191 368
64-detector CT 154 144 298
256-detector CT 113 112 225
Radiologist  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 444 participants 447 participants 891 participants
Abdominal radiologist 217 225 442
Non-abdominal radiologist 227 222 449
1.Primary Outcome
Title Negative Appendectomy
Hide Description Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)
Time Frame 1 week after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 172 186
Measure Type: Number
Unit of Measure: participants
Negative appendectomy 6 6
Not negative appendectomy 166 180
2.Secondary Outcome
Title Additional Imaging Test(s)
Hide Description Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis
Time Frame 1 week after CT
Hide Outcome Measure Data
Hide Analysis Population Description
All participants included in outcome analyses. Intention to treat. Complete case analysis.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 438 441
Measure Type: Number
Unit of Measure: participants
Additional imaging 14 7
No additional imaging 424 434
3.Secondary Outcome
Title Appendiceal Perforation
Hide Description Number of participants with appendiceal perforation
Time Frame 1 week after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 166 180
Measure Type: Number
Unit of Measure: participants
Perforation 44 42
No perforation 122 138
4.Secondary Outcome
Title Interval Between CT and Appendectomy
Hide Description Time interval between the CT acquisition and non-incidental appendectomy
Time Frame 1 day after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 172 186
Median (Inter-Quartile Range)
Unit of Measure: hr
7.1
(4.3 to 11.7)
5.6
(3.4 to 9.2)
5.Secondary Outcome
Title Interval Between CT and Discharge Without Surgery
Hide Description Time interval between the CT acquisition and discharge without surgery
Time Frame 3 months after CT
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who did not undergo surgery. Intention to treat. Complete case analysis.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 249 246
Median (Inter-Quartile Range)
Unit of Measure: hr
2.5
(1.5 to 4.2)
2.4
(1.4 to 4.4)
6.Secondary Outcome
Title Interval From CT to Discharge After Appendectomy
Hide Description Time interval between the CT acquisition and discharge after appendectomy
Time Frame 3 months after CT
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 172 186
Median (Inter-Quartile Range)
Unit of Measure: day
3.4
(2.7 to 4.1)
3.2
(2.5 to 4.1)
7.Secondary Outcome
Title Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description

Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.

There can be missing data if CT report was not made following predefined structured format.

Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 166 180
Measure Type: Number
Unit of Measure: participants
Grade 1 2 4
Grade 2 7 5
Grade 3 13 11
Grade 4 53 34
Grade 5 90 126
Missing 1 0
8.Secondary Outcome
Title Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description

Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.

There can be missing data if CT report was not made following predefined structured format.

Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 272 261
Measure Type: Number
Unit of Measure: participants
Grade 1 185 206
Grade 2 65 38
Grade 3 11 11
Grade 4 3 3
Grade 5 4 2
Missing 4 1
9.Secondary Outcome
Title Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description

Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.

There can be missing data if CT report was not made following predefined structured format.

Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 166 180
Measure Type: Number
Unit of Measure: participants
True positive 16 23
False positive 11 17
True negative 110 121
False negative 28 19
Missing 1 0
10.Secondary Outcome
Title Visualization of the Normal Appendix
Hide Description Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized
Time Frame 3 months after CT
Hide Outcome Measure Data
Hide Analysis Population Description

Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.

There can be missing data if CT report was not made following predefined structured format.

Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 272 261
Measure Type: Number
Unit of Measure: participants
Grade 0 18 13
Grade 1 41 20
Grade 2 209 227
Missing 4 1
11.Other Pre-specified Outcome
Title Radiation Dose
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who underwent CT. Intention to treat. Complete case analysis.
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description:
Aimed to 2 mSv in an average patient
Aimed to 8 mSv in an average patient
Overall Number of Participants Analyzed 444 447
Median (Inter-Quartile Range)
Unit of Measure: mGy•cm
116
(94 to 124)
521
(448 to 564)
12.Other Pre-specified Outcome
Title Estimate of Carcinogenic Risk Induced by CT Radiation
Hide 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
Outcome Measure Data Not Reported
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low-dose CT Standard-dose CT
Hide Arm/Group Description Aimed to 2 mSv in an average patient Aimed to 8 mSv in an average patient
All-Cause Mortality
Low-dose CT Standard-dose CT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low-dose CT Standard-dose CT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/444 (2.93%)      11/447 (2.46%)    
Gastrointestinal disorders     
Abdominal pain  1  6/444 (1.35%)  6 6/447 (1.34%)  6
Ileus  1  4/444 (0.90%)  4 4/447 (0.89%)  4
General disorders     
Fever  1  0/444 (0.00%)  0 1/447 (0.22%)  1
Injury, poisoning and procedural complications     
Wound complication  1  3/444 (0.68%)  3 0/447 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low-dose CT Standard-dose CT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/444 (0.23%)      1/447 (0.22%)    
Gastrointestinal disorders     
Abdominal pain  1  1/444 (0.23%)  1 1/447 (0.22%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
In this diagnostic trial, participants have a variety of abdominal diseases. Events with CTCAE v4 Grade 2 or less are not considered reportable according to the Study Protocol.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kyoung Ho Lee
Organization: Seoul National University Bundang Hospital
Phone: 82-31-787-7607
EMail: kholeemail@gmail.com
Layout table for additonal information
Responsible Party: Kyoung Ho Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00913380     History of Changes
Other Study ID Numbers: SNUBH-LDCTinAPPY
First Submitted: May 15, 2009
First Posted: June 4, 2009
Results First Submitted: June 27, 2011
Results First Posted: September 2, 2011
Last Update Posted: September 12, 2011