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

NCT ID: NCT00913380

Last Updated: 2011-09-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

891 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Low-dose CT

Group Type EXPERIMENTAL

Diagnostic CT

Intervention Type RADIATION

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

Standard-dose CT

Group Type ACTIVE_COMPARATOR

Diagnostic CT

Intervention Type RADIATION

8 mSv in an average patient (Standard-dose CT)

Interventions

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Diagnostic CT

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

Intervention Type RADIATION

Diagnostic CT

8 mSv in an average patient (Standard-dose CT)

Intervention Type RADIATION

Other Intervention Names

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low-dose CT standard-dose CT

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyoung Ho Lee

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyoung Ho Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Kyuseok Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 22533576 (View on PubMed)

Other Identifiers

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SNUBH-LDCTinAPPY

Identifier Type: -

Identifier Source: org_study_id

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