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Emergency Department CT Scanning for Appendicitis

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omnipaque
Sponsored by
WellSpan Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring Appendicitis, IV Contrast, Oral Contrast, CT scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis

Exclusion Criteria:

  • pregnant patients
  • patients with known IV dye or oral contrast allergy
  • patients in whom acute appendicitis is not the primary diagnosis
  • patients with renal insufficiency that may have significant adverse effect from IV dye

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    IV contrast

    IV contrast and oral contrast

    Outcomes

    Primary Outcome Measures

    sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient.

    Secondary Outcome Measures

    If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient

    Full Information

    First Posted
    August 12, 2008
    Last Updated
    June 27, 2012
    Sponsor
    WellSpan Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00734825
    Brief Title
    Emergency Department CT Scanning for Appendicitis
    Official Title
    Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    WellSpan Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency department. A secondary purpose will be to design a specific CT for appendicitis protocol at our institution at the conclusion of this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendicitis
    Keywords
    Appendicitis, IV Contrast, Oral Contrast, CT scan

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    244 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    IV contrast
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    IV contrast and oral contrast
    Intervention Type
    Other
    Intervention Name(s)
    Omnipaque
    Intervention Description
    oral contrast for CT scan
    Primary Outcome Measure Information:
    Title
    sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient.
    Time Frame
    immediate reading + blinded reading within 48 hours
    Secondary Outcome Measure Information:
    Title
    If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient
    Time Frame
    immediate reading and blinded reading within 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis Exclusion Criteria: pregnant patients patients with known IV dye or oral contrast allergy patients in whom acute appendicitis is not the primary diagnosis patients with renal insufficiency that may have significant adverse effect from IV dye
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Kepner, MD
    Organizational Affiliation
    WellSpan Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22633722
    Citation
    Kepner AM, Bacasnot JV, Stahlman BA. Intravenous contrast alone vs intravenous and oral contrast computed tomography for the diagnosis of appendicitis in adult ED patients. Am J Emerg Med. 2012 Nov;30(9):1765-73. doi: 10.1016/j.ajem.2012.02.011. Epub 2012 May 23.
    Results Reference
    derived

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    Emergency Department CT Scanning for Appendicitis

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