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OpenTrials
Completed

NCT Number: NCT01790139

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral simethicone

Drug

10 mL of simethicone is administered as an agent to prevent colonic bubbles

Other names: Simethicone manufactured by Taejoon Pharm Co., Ltd.

Primary outcomes

  1. Colonic bubble-related image quality

    Time frame: 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 outcomes

  1. Overall image quality

    Time frame: 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.

  2. diagnostic performance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2013
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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