Clinical trial NCT01655550: The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence
Official title: The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Routine Outpatients Undergoing Contrast Enhanced CT Scan of the Abdomen and Pelvis
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 216
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Radiologist Confidence
timeFrame: one-time measurement after scan completion
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Jefferson Radiology
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Christopher M Garcia, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: