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

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

Sponsors

Lead Sponsor: Duke University

Source Duke University
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.

Overall Status Completed
Start Date May 2008
Completion Date January 2009
Primary Completion Date January 2009
Study Type Observational
Primary Outcome
Measure Time Frame
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. immediate
Secondary Outcome
Measure Time Frame
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 immediate
Enrollment 102
Condition
Intervention

Intervention Type: Device

Intervention Name: radio-opaque adhesive skin markers

Description: The examining physician will place a radio-opaque skin marker (Beekley Corporation, Ortho-SPOTS® Order Code 187; 6mm spherical markers) at the point of maximal tenderness to direct abdominal palpation indicated by the patient. Additional markers will be placed at the cephalad and caudad limits of the region of tenderness, defined as the point at which the patient no longer complains of direct tenderness to palpation.

Arm Group Label: 1

Eligibility

Sampling Method: Non-Probability Sample

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: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Joshua S Broder, MD Principal Investigator Duke University Health System
Location
Facility: Duke University Medical Center
Location Countries

United States

Verification Date

February 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Duke University

Investigator Full Name: Joshua Broder

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 1

Description: All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, except for those meeting pre-specified exclusion criteria.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov