Colorectal Neoplasms
Conditions
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.
Interventions
DRUGOral simethicone
10 mL of simethicone is administered as an agent to prevent colonic bubbles
Sponsors
GE Healthcare
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonic bubble-related image quality | within 1 month after assessment of the other primary endpoint | Colonic bubble-specific image quality is evaluated semi-quantitatively in terms of colonic mucosal surface obscured/covered by colonic bubbles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall image quality | within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients | Overall image quality according to the CT Colonography Reporting and Data System. Rate of C0, i.e. polyps 1 cm or larger cannot be excluded due to insufficient technical quality, is assessed. |
| diagnostic performance | within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients | diagnostic performance of CT colonography for detecting colonic adenoma or carcinoma 6 mm or greater in diameter |
Countries
South Korea
Outcome results
None listed