Clinical Trial: Limited Abdominal CT in ED Patients With Abdominal Pain

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Prospective Study of Z-axis-limited Abdominal CT Guided by Region of Tenderness in the Diagnosis and Management of Adult Emergency Department Patients With Acute Nontraumatic Abd

Brief Summary:

The purpose of the study is to compare the diagnosis and management (treatment and disposition) of adult emergency department patients with acute nontraumatic abdominal pain and tenderness, based on two CT techniques:

  1. Standard (complete) abdominal-pelvic CT. The American College of Radiology calls for the cephalad limit of abdominal CT to begin at the dome of the diaphragm, and the caudad limit of pelvic CT to extend through the ischial tuberosities.
  2. A z-axis restricted subset of images digitally obtained from the original CT dataset, determined by the region of tenderness identified by the examining emergency physician and marked on the patient prior to the performance of the CT. This z-axis restricted CT does not require any additional radiation exposure to the patient, as it will be produced by computer extraction of data from the original standard abdominal-pelvic CT.

The investigators hypothesize that the diagnosis and management will not differ when guided by the two CT scan interpretations. Radiation doses will be calculated for each of the two techniques.


Detailed Summary:

This will be a prospective study with informed consent from patient subjects.

Informed consent will be obtained prior to subject enrollment. The study protocol requires the following steps to be performed, each of which is described in more detail later in this document:

  1. Potential patient subject is identified by research staff, by virtue of abdominal-pelvic CT being ordered for clinical evaluation of nontraumatic abdominal pain and tenderness, as determined by a board-certified attending emergency physician.
  2. Research staff applies inclusion and exclusion criteria to confirm patient eligibility.
  3. Potential subjects who fail one or more inclusion or meet one or more exclusion criteria are recorded in electronic research log with reason for exclusion but are not asked to participate in study. Recorded information includes age (if greater than 89, will simply be recorded as "greater than 89"), gender, race/ethnicity, date, and reason for exclusion. No identifiers are recorded for these patients. The purpose of this information is to allow comparison of the enrolled group with all patients with abdominal pain undergoing CT. This will be part of a CONSORT flow diagram, allowing readers to understand potential selection bias and to understand the probable clinical population in the context of all emergency department's (ED) patients undergoing abdominal CT.
  4. Eligible potential subjects (meeting all inclusion and no exclusion criteria) are asked to participate in study with informed consent. The study will be introduced to potential subjects by the emergency physician caring for this patient. The study will be introduced only after CT for evaluation of abdominal pain and tenderness is or
    Sponsor: Duke University

    Current Primary Outcome: Diagnosis, treatment and disposition [ Time Frame: Records will be reviewed from the ED visit date to the date of discharge from the hospital or up to 30 days following ED visit, whichever comes last ]

    The diagnosis, treatment, and disposition plans based on the z-axis restricted CT and the full CT will be compared for agreement.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: radiation reduction [ Time Frame: Records will be reviewed 30 days after the ED visit or date of discharge from the hospital, whichever comes first ]

    The radiation doses resulting from a z-axis restricted CT and the full CT will be compared using dose-length products.


    Original Secondary Outcome: Same as current

    Information By: Duke University

    Dates:
    Date Received: May 15, 2014
    Date Started: November 2017
    Date Completion: May 2019
    Last Updated: April 25, 2017
    Last Verified: March 2017