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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

Tracking Information
First Submitted Date  ICMJE May 15, 2009
First Posted Date  ICMJE June 4, 2009
Results First Submitted Date  ICMJE June 27, 2011
Results First Posted Date  ICMJE September 2, 2011
Last Update Posted Date September 12, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Negative Appendectomy [ Time Frame: 1 week after surgery ]
Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Negative appendectomy rate (# of unnecessary appendectomies [removal of un-inflamed appendix] / # of total appendectomies ) [ Time Frame: 1 week after surgery ]
Change History Complete list of historical versions of study NCT00913380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
  • 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
  • Appendiceal Perforation [ Time Frame: 1 week after surgery ]
    Number of participants with appendiceal perforation
  • Interval Between CT and Appendectomy [ Time Frame: 1 day after surgery ]
    Time interval between the CT acquisition and non-incidental appendectomy
  • Interval Between CT and Discharge Without Surgery [ Time Frame: 3 months after CT ]
    Time interval between the CT acquisition and discharge without surgery
  • Interval From CT to Discharge After Appendectomy [ Time Frame: 3 months after CT ]
    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 ]
    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 ]
    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 ]
    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 ]
    Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
  • Appendicitis perforation rate [ Time Frame: 1 week after surgery ]
  • Diagnostic performance for appendicitis (sensitivity, specificity, and area under the receiver-operating-characteristic curve) [ Time Frame: 6 months after initial presentation ]
  • Diagnostic sensitivity for alternative diagnoses [ Time Frame: 6 months after intial presentation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
Official Title  ICMJE Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Appendicitis
Intervention  ICMJE
  • Radiation: Diagnostic CT
    2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
    Other Name: low-dose CT
  • Radiation: Diagnostic CT
    8 mSv in an average patient (Standard-dose CT)
    Other Name: standard-dose CT
Study Arms  ICMJE
  • Experimental: Low-dose CT
    Intervention: Radiation: Diagnostic CT
  • Active Comparator: Standard-dose CT
    Intervention: Radiation: Diagnostic CT
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2011)
891
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
896
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913380
Other Study ID Numbers  ICMJE SNUBH-LDCTinAPPY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyoung Ho Lee, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE
  • GE Healthcare
  • National Research Foundation of Korea
Investigators  ICMJE
Principal Investigator: Kyoung Ho Lee, MD Seoul National University Bundang Hospital
Principal Investigator: Kyuseok Kim, MD Seoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP