Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Colonic bubble-related image quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Intervention-Oral Simethicone
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.
干预措施: Oral simethicone (Drug)
结局指标
主要结局
Colonic bubble-related image quality
时间窗: 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.
次要结局
- Overall image quality(within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients)
- diagnostic performance(within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients)
研究者
Seong Ho Park
Associate Professor
Asan Medical Center