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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 Description
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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.

Condition or disease Intervention/treatment Phase
Appendicitis Radiation: Diagnostic CT Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 891 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
Study Start Date : September 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low-dose CT Radiation: Diagnostic CT
2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
Other Name: low-dose CT
Active Comparator: Standard-dose CT Radiation: Diagnostic CT
8 mSv in an average patient (Standard-dose CT)
Other Name: standard-dose CT


Outcome Measures
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Primary Outcome Measures :
  1. Negative Appendectomy [ Time Frame: 1 week after surgery ]
    Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)


Secondary Outcome Measures :
  1. Additional Imaging Test(s) [ Time Frame: 1 week after CT ]
    Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis

  2. Appendiceal Perforation [ Time Frame: 1 week after surgery ]
    Number of participants with appendiceal perforation

  3. Interval Between CT and Appendectomy [ Time Frame: 1 day after surgery ]
    Time interval between the CT acquisition and non-incidental appendectomy

  4. Interval Between CT and Discharge Without Surgery [ Time Frame: 3 months after CT ]
    Time interval between the CT acquisition and discharge without surgery

  5. Interval From CT to Discharge After Appendectomy [ Time Frame: 3 months after CT ]
    Time interval between the CT acquisition and discharge after appendectomy

  6. Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis [ Time Frame: 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.


  7. Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis [ Time Frame: 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.


  8. Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis. [ Time Frame: 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.


  9. Visualization of the Normal Appendix [ Time Frame: 3 months after CT ]
    Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized


Other Outcome Measures:
  1. Radiation Dose [ Time Frame: 1 day after CT ]
    Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The "length" indicates the scan range.

  2. Estimate of Carcinogenic Risk Induced by CT Radiation [ Time Frame: 1 day after CT ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913380


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
GE Healthcare
National Research Foundation of Korea
Investigators
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Principal Investigator: Kyoung Ho Lee, MD Seoul National University Bundang Hospital
Principal Investigator: Kyuseok Kim, MD Seoul National University Bundang Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kyoung Ho Lee, Dr., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00913380    
Other Study ID Numbers: SNUBH-LDCTinAPPY
First Posted: June 4, 2009    Key Record Dates
Results First Posted: September 2, 2011
Last Update Posted: September 12, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infections
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases