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

A

Asan Medical Center

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Drug: Oral simethicone

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01790139
2012-0584

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

84 participants in 2 patient groups

Control
No Intervention group
Description:
Control group undergoes CT colonography after usual cathartic bowel cleansing using Colonlyte and fecal/fluid tagging. The tagging is done by administering orally 50 mL of iohexol (Omnipaque 350, GE Healthcare) 10 minutes after the completion of Colonlyte.
Intervention-Oral Simethicone
Experimental group
Description:
Intervention group undergoes CT colonography after usual cathartic bowel cleansing using Colonlyte, fecal/fluid tagging, and oral administration of simethicone. The tagging is done by administering orally 50 mL of iohexol (Omnipaque 350, GE Healthcare) 10 minutes after the completion of Colonlyte. As the interventional procedure in this intervention group, 10 mL of simethicone is administered orally immediately following the administration of iohexol.
Treatment:
Drug: Oral simethicone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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