Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Duke University
Information provided by (Responsible Party):
Joshua Broder, Duke University
ClinicalTrials.gov Identifier:
NCT00673374
First received: March 9, 2008
Last updated: January 16, 2013
Last verified: January 2013
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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 ]
| Estimated Enrollment: | 2400 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | July 2013 |
| 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
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: | January 16, 2013 |
| 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 Congenital Abnormalities Emergencies Pain |
Signs and Symptoms Signs and Symptoms, Digestive Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013