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

NCT ID: NCT01655550

Last Updated: 2012-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

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

Conditions

Routine Outpatients Undergoing Contrast Enhanced CT Scan of the Abdomen and Pelvis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard of Care

Patients will get routine CT scans with Oral and Intravenous contrast prior to their CT scan as is routine, standard practice

Group Type: OTHER

Withhold oral contrast

Intervention Type: OTHER

The intervention is to withhold oral contrast

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

Group Type: EXPERIMENTAL

Withhold oral contrast

Intervention Type: OTHER

The intervention is to withhold oral contrast

Interventions

Withhold oral contrast

The intervention is to withhold oral contrast

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher M Garcia, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Jefferson Radiology

Hartford, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chris Garcia, MD MHS

Role: CONTACT

Phone: 860 545 5240

Email: cgarcia06@harthosp.org

Facility Contacts

Bret Coughlin, MD

Role: primary

Other Identifiers

GARC003501

Identifier Type: -

Identifier Source: org_study_id