Recruiting

Observational Study

Sponsor:

Hartford Hospital

Code:

NCT01655550

Conditions

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

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Withhold oral contrast

Study Details

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.

Conditions

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

Study ID

NCT01655550

Start date

Jun, 2012

Status verified date

Jul, 2012

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

Interventions

Withhold oral contrast

The intervention is to withhold oral contrast

Primary outcome measure

  • Radiologist Confidence [ Time Frame: one-time measurement after scan completion ]

Central Contacts and Locations

Central contacts

Chris Garcia, MD MHS

860 545 5240cgarcia06@harthosp.org

Locations

Jefferson Radiology

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Bret Coughlin, MD

860-545-5240bcoughlin@jeffersonradiology.com

Principal Investigator:

Christopher M Garcia, MD MHS

More Information

Sponsor

Hartford Hospital

Last update posted

Aug 2, 2012

Last verified

Jul, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2012-08-02.