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Completed

NCT Number: NCT00673374

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 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

    Time frame: immediate

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 7, 2008
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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