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.

Study Overview

• Status: Unknown
• Conditions: Routine Outpatients Undergoing Contrast Enhanced CT Scan of the Abdomen and Pelvis
• Intervention / Treatment: Other: 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

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chris Garcia, MD MHS; Phone Number: 860 545 5240; Email: cgarcia06@harthosp.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Jefferson Radiology
      • Sub-Investigator: Steve Lee, MD
      • Contact: Bret Coughlin, MD; Phone Number: 860-545-5240; Email: 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 Boe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiologist Confidence	Confidence graded by the radiologist on a scale of 1 to 10	one-time measurement after scan completion

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Investigators: Principal Investigator: Christopher M Garcia, MD MHS, Hartford Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Estimate): August 2, 2012
• Last Update Submitted That Met QC Criteria: August 1, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: GARC003501