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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 9, 2008 | ||||
| Last Updated Date | December 26, 2008 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00673374 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients | ||||
| Official Title ICMJE | Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Abdominal Pain | ||||
| Intervention ICMJE | Device: radio-opaque adhesive skin markers | ||||
| Study Arms / Comparison Groups | 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. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 2400 | ||||
| Estimated Completion Date | July 2010 | ||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00673374 | ||||
| Responsible Party | Joshua Broder, MD, Duke University Health System | ||||
| Study ID Numbers ICMJE | Pro00004904 | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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