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Clinical Trials/NCT05878665
NCT05878665
Recruiting
Not Applicable

Optimizing Low-dose Contrast Media Protocol for Low-kVp Abdominopelvic CT in Suspected Acute Appendicitis

Bohyun Kim1 site in 1 country292 target enrollmentDecember 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Appendicitis Acute
Sponsor
Bohyun Kim
Enrollment
292
Locations
1
Primary Endpoint
Diagnostic accuracy for acute appendicitis
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The purpose of this clinical study is to test the performance of low radiation dose abdominal CT combined with low dose contrast media for the diagnosis of acute appendicitis in young patients. The main questions to be answered are:

1, Can low-dose contrast media paired with low-dose radiation CT of the abdomen provide acceptable diagnostic accuracy in acute appendicitis? 2. How much radiation dose can be saved by using low radiation dose abdominal CT in combination with low dose contrast media?

Registry
clinicaltrials.gov
Start Date
December 21, 2023
End Date
December 31, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Bohyun Kim
Responsible Party
Sponsor Investigator
Principal Investigator

Bohyun Kim

Associate professor

Seoul St. Mary's Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Diagnostic accuracy for acute appendicitis

Time Frame: For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU

The primary outcome of the study is the diagnostic accuracy of double low-dose CT for acute appendicitis in young adults with suspected acute appendicitis. Based on the CT findings, a three-tiered diagnosis of appendicitis will be given (no appendicitis, uncomplicated appendicitis, or complicated appendicitis). In the case of no appendicitis, a possible alternative diagnosis is given. The reference standard for appendicitis is operative findings and surgical pathology reports. In nonoperative cases, sequential radiologic evaluation, clinical follow-up, and the judgment of the attending physician will conclude the diagnosis. Specifically, if the patient is not treated for recurrent symptoms within 6 months, the radiologic diagnosis of CT findings is considered valid. The diagnostic accuracy for acute appendicitis is true positive for acute appendicitis and true negative for acute appendicitis divided by all participants.

Study Sites (1)

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