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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joshua Broder, Duke University
ClinicalTrials.gov Identifier:
NCT00673374
First received: March 9, 2008
Last updated: February 23, 2014
Last verified: February 2014
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 102
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Joshua Broder, Associate Professor, Duke University
ClinicalTrials.gov Identifier: NCT00673374     History of Changes
Other Study ID Numbers: Pro00004904
Study First Received: March 9, 2008
Last Updated: February 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
emergency
acute
nontraumatic
abdominal pain
tenderness
CT scan
radiation
diagnosis

Additional relevant MeSH terms:
Abdominal Pain
Emergencies
Disease Attributes
Pain
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014