Clinical trial NCT01790139: Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles
Official title: Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2013-02-13
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Detailed description: CT colonography (CTC) is a recently developed radiological examination to find colorectal neoplasia. Fecal/fluid tagging using oral administration of contrast is an essential procedure for CTC. Iohexol, which has recently started being used as an agent for fecal/fluid tagging, has great advantages as it has much more tolerable taste and much lower rates of adverse effects such as clamping or diarrhea compared with traditionally used Gastrografin/Gastroview. However, iohexol is frequently associated with an occurrence of a lot of bubbles in the colon, which makes CTC interpretation more time-consuming and laborious.

Past experience in colonoscopy field suggests that simethicone, a safety-proven highly inexpensive over-the-counter medicine, might resolve this issue. Given the fact that patient convenience is an important factor for a successful CTC and the fact that time-intensive nature of CTC interpretation is one of the major deterrents to wide spread adoption of CTC while CTC also needs to be as time efficient as possible in order to effectively serve the role of population screening for colorectal cancer, investigating the effect of simethicone to prevent the colonic bubbles on the time efficiency of CTC interpretation would be important. If simethicone can resolve the colonic bubble problem, CTC can be performed more conveniently for the patients as well as for the interpreting radiologists.

This study is to determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Eligibility criteria: Inclusion Criteria:

* Adult patients who are schedule to undergo colonoscopy for a suspicion of colonic neoplasia at the investigators' institution
* Those who agree to participate in the study

Exclusion Criteria:

* Colonoscopy for reasons other than detecting colonic neoplasia, e.g. evaluation of inflammatory bowel disease
* Contraindications to iodinated contrast including renal insufficiency, hypersensitivity, and hyperthyroidism
* Acute severe colonic obstruction which is likely preclude safe and successful performance of CTC
* Patient who is suspicious for colonic perforation
* Pregnancy
* Phenylketonuria (contraindication to simethicone)

Primary outcomes:
measure: Colonic bubble-related image quality
timeFrame: within 1 month after assessment of the other primary endpoint
Secondary outcomes:
measure: Overall image quality
timeFrame: within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients
measure: diagnostic performance
timeFrame: within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Seong Ho Park, MD
role: PRINCIPAL_INVESTIGATOR
References: