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Completed

NCT Number: NCT00913380

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

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.

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Key information

Conditions

Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

15 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic CT

Radiation

2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))

Other names: low-dose CT

Primary outcomes

  1. Negative Appendectomy

    Time frame: 1 week after surgery

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

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • GE Healthcare
  • National Research Foundation of Korea

Registry information

Official study title

Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 4, 2009
Registry last updated
Sep 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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