The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence

This study is currently recruiting participants.
Verified July 2012 by Hartford Hospital
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01655550
First received: July 31, 2012
Last updated: August 1, 2012
Last verified: July 2012

July 31, 2012
August 1, 2012
June 2012
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01655550 on ClinicalTrials.gov Archive Site
 
 
 
 
 
The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence
The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence: A Randomized Controlled Trial

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.

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

Interventional
 
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Routine Outpatients Undergoing Contrast Enhanced CT Scan of the Abdomen and Pelvis
Other: Withhold oral contrast
The intervention is to withhold oral contrast
  • Standard of Care
    Patients will get routine CT scans with Oral and Intravenous contrast prior to their CT scan as is routine, standard practice
    Intervention: Other: Withhold oral contrast
  • Experimental: Withold Oral Contrast
    Subjects will not drink oral contrast, but instead water (in itself a type of contrast agent) prior to their CT. Intravenous contrast will be administered as is routine
    Intervention: Other: Withhold oral contrast
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
216
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • order for "Contrast Enhanced abdomen CT" or "Contrast Enhanced abdomen/pelvis CT"

    • age ≥21
    • able and willing to give consent

Exclusion Criteria:

  • • allergy to IV contrast

    • order for non-contrast CT
    • <21
    • pregnant woman
    • order for enterography or colonography
    • history of Crohn's Disease or Ulcerative Colitis
Both
21 Years and older
Yes
Contact: Chris Garcia, MD MHS 860 545 5240 cgarcia06@harthosp.org
United States
 
NCT01655550
GARC003501
No
Hartford Hospital
Hartford Hospital
 
Principal Investigator: Christopher M Garcia, MD MHS Hartford Hospital
Hartford Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP