Limited Abdominal CT in ED Patients With Abdominal Pain

NCT02146521 | Withdrawn

• 1 other identifier: Pro00050303
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Abdominal Pain

Keywords

z-axis limited CT; computed tomography; CT; abdominal non-traumatic pain and tenderness; emergency patients

Outcome Measures

Primary Outcomes (1)

• Diagnosis, treatment and disposition

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

  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

Secondary Outcomes (1)

• radiation reduction

  Records will be reviewed 30 days after the ED visit or date of discharge from the hospital, whichever comes first

Study Arms (1)

patients undergoing CT

Emergency department's patients undergoing CT scanning for evaluation of acute abdominal pain and tenderness

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the emergency department undergoing CT evaluation for acute abdominal pain and tenderness

You may qualify if:

• emergency department's patients undergoing CT evaluation for acute abdominal pain and tenderness (acute is defined as onset of current episode within 7 days of emergency department presentation).

You may not qualify if:

• neurological disorders
• altered mental status
• history of intra-abdominal surgery in the past 30 days
• BMI higher than 35
• immunocompromised patients
• abdominal trauma in the past 30 days
• CT is ordered for the following indications:
• isolated vomiting
• fever without source
• staging of malignancy
• isolated flank pain or suspected renal colic

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Joshua S Broder, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 26, 2014
• Study Start: November 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

US (1)