Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00673374

Purpose

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.

Condition	Intervention
Abdominal Pain	Device: radio-opaque adhesive skin markers

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients

Further study details as provided by Duke University:

Primary Outcome Measures:

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 Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2400
Study Start Date:	May 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 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.

Groups/Cohorts

Assigned Interventions

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

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673374

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Joshua S Broder, MD

Duke University Health System

More Information

No publications provided

Responsible Party:	Duke University Health System ( Joshua Broder, MD )
Study ID Numbers:	Pro00004904
Study First Received:	March 9, 2008
Last Updated:	December 26, 2008
ClinicalTrials.gov Identifier:	NCT00673374 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

emergency
acute
nontraumatic
abdominal pain

tenderness
CT scan
radiation
diagnosis

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain

Emergencies
Pain
Congenital Abnormalities

Additional relevant MeSH terms:

Signs and Symptoms
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive

Abdominal Pain
Emergencies
Pain

ClinicalTrials.gov processed this record on May 07, 2009