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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
History of Changes
  Purpose

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.


Condition Intervention
Routine Outpatients Undergoing Contrast Enhanced CT Scan of the Abdomen and Pelvis
 Other: Withhold oral contrast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 216
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard of Care
Patients will get routine CT scans with Oral and Intravenous contrast prior to their CT scan as is routine, standard practice
 Other: Withhold oral contrast
The intervention is to 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
 Other: Withhold oral contrast
The intervention is to withhold oral contrast

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655550

Contacts
Contact: Chris Garcia, MD MHS 860 545 5240 cgarcia06@harthosp.org

Locations
United States, Connecticut
Jefferson Radiology Recruiting
Hartford, Connecticut, United States, 06102
Contact: Bret Coughlin, MD     860-545-5240     bcoughlin@jeffersonradiology.com    
Sub-Investigator: Bret Coughlin, MD            
Principal Investigator: Christopher M Garcia, MD MHS            
Sub-Investigator: Doug Moote, MD            
Sub-Investigator: Michael O'Loughlin, MD            
Sub-Investigator: Davika Jajoo, MD            
Sub-Investigator: Steve Lee, MD            
Sub-Investigator: Steve Boe, MD            
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Christopher M Garcia, MD MHS Hartford Hospital
  More Information

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01655550     History of Changes
Other Study ID Numbers: GARC003501
Study First Received: July 31, 2012
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013