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Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients

This study is not yet open for participant recruitment.
Study NCT00673374.   Last updated on May 4, 2008.   Information provided by Duke University

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Descriptive Information Fields
Brief Title  Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients
Official Title  Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients
Brief Summary

To determine the correlation between the region of abdominal tenderness determined by the examining physician and the location of acute pathology diagnosed on abdominal CT. We hypothesize that the acute pathology diagnosed by CT will lie within the region marked on the abdominal wall by the examining physician prior to CT.

Detailed Description
Study Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure  sensitivity and specificity of a hypothetical limited CT restricted to the region of abdominal tenderness for detection of acute pathology on CT on the entire abdomen. [ Time Frame: immediate ] [ Designated as safety issue: No ]
Secondary Outcome Measure  the percentage decrease in radiation exposure which could be achieved by performing a CT restricted to the region of abdominal tenderness, compared with CT of the entire abdomen [ Time Frame: immediate ] [ Designated as safety issue: Yes ]
Condition  Abdominal Pain
Intervention  Device: radio-opaque adhesive skin markers
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  2400
Start Date  May 2008
Completion Date May 2009
Eligibility Criteria 

Inclusion Criteria:

  • All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled.

Exclusion Criteria:

  • Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study.
  • Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded.
  • Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness.
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Contact: Joshua S Broder, MD     919-681-2247     jbroder@nc.rr.com    
Contact: Erik Paulson, MD     919 684 7366     pauls003@mc.duke.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00673374
Organization ID Pro00004904
Secondary IDs ††
Study Sponsor  Duke University
Collaborators ††
Investigators 
Principal Investigator:     Joshua S Broder, MD     Duke University Health System    
Information Provided By Duke University
Verification Date May 2008
First Received Date  March 9, 2008
Last Updated Date May 4, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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