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

This study has been completed.
Sponsor:
Collaborators:
GE Healthcare
National Research Foundation of Korea
Information provided by (Responsible Party):
Kyoung Ho Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00913380
First received: May 15, 2009
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Appendicitis
 Radiation: Diagnostic CT
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Negative Appendectomy [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]
    Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)


Secondary Outcome Measures:
  • Additional Imaging Test(s) [ Time Frame: 1 week after CT ] [ Designated as safety issue: No ]
    Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis

  • Appendiceal Perforation [ Time Frame: 1 week after surgery ] [ Designated as safety issue: Yes ]
    Number of participants with appendiceal perforation

  • Interval Between CT and Appendectomy [ Time Frame: 1 day after surgery ] [ Designated as safety issue: No ]
    Time interval between the CT acquisition and non-incidental appendectomy

  • Interval Between CT and Discharge Without Surgery [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]
    Time interval between the CT acquisition and discharge without surgery

  • Interval From CT to Discharge After Appendectomy [ Time Frame: 3 months after CT ] [ Designated as safety issue: Yes ]
    Time interval between the CT acquisition and discharge after appendectomy

  • Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]

    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. [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]
    Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized


Enrollment: 891
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913380

Locations
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
Principal Investigator: Kyoung Ho Lee, MD Seoul National University Bundang Hospital
Principal Investigator: Kyuseok Kim, MD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Kyoung Ho Lee, Dr., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00913380     History of Changes
Other Study ID Numbers: SNUBH-LDCTinAPPY
Study First Received: May 15, 2009
Results First Received: June 27, 2011
Last Updated: September 2, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013