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

NCT00673374 | Completed

• 1 other identifier: Pro00004904
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Keywords

emergency; acute; nontraumatic; abdominal pain; tenderness; CT scan; radiation; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1

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.

Device: radio-opaque adhesive skin markers

Interventions

radio-opaque adhesive skin markers DEVICE

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Abdominal Pain; Emergencies; Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Disease Attributes; Pathologic Processes

Study Officials

• Joshua S Broder, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

US (1)