NCT02556983

Brief Summary

The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

September 18, 2015

Last Update Submit

April 11, 2017

Conditions

Appendicitis

Keywords

AppendicitisTomography, X-Ray ComputedReceiver operating characteristic (ROC) CurveComputer Simulation

Outcome Measures

Primary Outcomes (4)

  • Diagnostic performance at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    The pooled area under curve (AUC) from three radiologists

    2 months

  • Diagnostic performance at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    The pooled AUC from three radiologists

    1 months

  • Diagnostic performance at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    \*The analysis of 50%-dose CT images will be performed only if non-inferiority of 75%-dose CT to the original CT is proven in terms of the pooled AUC. The pooled AUC from three radiologists

    8 months

  • Diagnostic performance at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    \*The analysis of 25%-dose CT images will be performed only if non-inferiority of 50%-dose CT is proven to the original CT in terms of the pooled AUC. The pooled AUC from three radiologists

    14 months

Secondary Outcomes (24)

  • Sensitivity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    2 months

  • Specificity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    2 months

  • Sensitivity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    1 month

  • Specificity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    1 month

  • Sensitivity at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist

    8 months

  • +19 more secondary outcomes

Study Arms (1)

Suspected appendicitis

Patients who are suspected as having acute appendicitis

Radiation: CT

Interventions

CTRADIATION

Contrast-enhanced CT images of the abdomen and pelvis will be obtained during the portal venous phase using a 256-channel CT system (Philips Healthcare, Cleveland, OH). The target median dose-length product (DLP) is 130 mGy·cm, which corresponded to an effective dose of 2 mSv with a conversion factor of 0.015 mSv·mGy-1·cm-1. The radiation output was automatically adjusted according to the individual patient's body size.

Suspected appendicitis

Eligibility Criteria

Age15 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Emergency department visit with suspected symptoms and signs of acute appendicitis.

You may qualify if:

  • years of age.
  • Emergency department visit with suspected symptoms and signs of acute appendicitis
  • Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis

You may not qualify if:

  • having contraindications of intravenous contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bunadang Hospital

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

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Ji Hoon Park, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 22, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

KR(1)