The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence
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First Received Date ICMJE | July 31, 2012 | ||||
Last Updated Date | August 1, 2012 | ||||
Start Date ICMJE | June 2012 | ||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Radiologist Confidence [ Time Frame: one-time measurement after scan completion ] [ Designated as safety issue: No ] Confidence graded by the radiologist on a scale of 1 to 10 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01655550 on ClinicalTrials.gov Archive Site | ||||
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Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence | ||||
Official Title ICMJE | The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence: A Randomized Controlled Trial | ||||
Brief Summary | The investigators seek to demonstrate the non-superiority of oral contrast versus no oral contrast in intravenously enhanced CT in the outpatient setting. The investigators want to decrease preparation time for the patient and decrease delay in obtaining the study which will ultimately lead to faster results and an increased level of patient convenience. The investigators hypothesis: Oral contrast does not significantly affect the diagnostic confidence of interpreting radiologists in intravenously enhanced abdominal CT scans. |
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Detailed Description | This study will be a randomized controlled trial comparing radiologist confidence when faced with an intravenously enhanced study with and without oral contrast. At the time of making the appointment, the clerk will ask the patient if he/she wishes to participate in a research study about the impact of oral contrast. If the patient assents, he/she will receive a phone call from a research assistant to obtain informed consent. The first ten patients to call the office to schedule a scan using a 64 slice MDCT will be recruited and randomized if they consent. Subjects will be randomized at the time of recruitment, which will be when he/she calls to make the appointment for the exam, in a 1:1 ratio between the control arm (contrast) and the experimental arm (no contrast). The control arm will either pick up their two bottles of oral contrast at a radiology office or have the bottles mailed to them as is currently the standard. They will drink the oral contrast two hours before the study. They will also ingest 300 mL of water immediately prior to imaging and be administered the standard intravenous contrast dose. The experimental group will not be mailed or given any oral contrast. They will arrive at their appointment and ingest 300 mL of water immediately prior to the exam as well as the standard intravenous contrast dose and be scanned. This design will eliminate the need to repeat scanning patients, thus decreasing radiation dose. A patient satisfaction survey will be given to each patient following the exam and handed to the technologist |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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Condition ICMJE | Routine Outpatients Undergoing Contrast Enhanced CT Scan of the Abdomen and Pelvis | ||||
Intervention ICMJE | Other: Withhold oral contrast
The intervention is to withhold oral contrast |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 216 | ||||
Estimated Completion Date | June 2013 | ||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01655550 | ||||
Other Study ID Numbers ICMJE | GARC003501 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Hartford Hospital | ||||
Study Sponsor ICMJE | Hartford Hospital | ||||
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Investigators ICMJE |
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Information Provided By | Hartford Hospital | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |