Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles

Colorectal Neoplasms Clinical Trial

Official title: Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms

• NCT number: NCT01790139
• Study type: Interventional
• Source: Asan Medical Center
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: January 2014