跳至主要内容
临床试验/NCT04087265
NCT04087265撤回不适用

Accuracy of Trans Abdominal Ultrasound in Evaluating Bowel Preparation Adequacy Before Performing Colonoscopy

Johns Hopkins University0 个研究点开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Accuracy of transabdominal ultrasound in evaluating bowel preparation adequacy before colonoscopy as assessed by the Boston Bowel Preparation Scale (BPPS)

研究概览

简要总结

Adequate preparation of the large bowel is required for a successful colonoscopy. It has been reported that poor preparation exists in 25% of examinations, which may lengthen overall procedure time, lower adenoma detection rate, and lead to earlier repeated colonoscopy. Evaluating the large intestine preparation by transabdominal ultrasonography can be a helpful way to predict the quality of the colonoscopy before initiating the process and therefore prevent performing the procedure in case of inadequate preparation. Estimating the colon preparation using an easy, fast and low cost way as transabdominal ultrasound before performing the colonoscopy would help the physician determine the next step. In case of poor preparation, colonoscopy can be postponed and the patient can be saved from repeated colonoscopy. The aim of this is to determine the accuracy of transabdominal ultrasonography in evaluating bowel preparation adequacy before performing colonoscopy.

详细描述

Colonoscopy is the most effective method of visualizing the colon mucosa. Adequate bowel preparation, which leads to clear visualization of mucosal surface of the colon, is important for a successful colonoscopy. Studies have shown that inadequate bowel preparation increases the adenoma detection failure, decreases the accuracy, prolongs the procedure time, decreases surveillance intervals, increases costs and results in procedure related complications. Poor preparation affects as many as 25% of colonoscopies and leads to an increase cost of colonoscopies. Endoscopists have long struggled to find the most appropriate follow-up strategy when the quality of bowel preparation is suboptimal. There is evidence of surveillance overuse in low-risk patients as well as underuse in high-risk patients.

Using a non-invasive, low cost approach for evaluating the bowel preparation before initiating the colonoscopy can save the patient from additional costs and procedures. Sonography has been used as a method of evaluating bowel condition in some colorectal diseases, mostly in Crohn's disease. Advantages of using ultrasound are that it is widely available, none-invasive, does not require preparation and lacks radiation exposure.

Transabdominal bowel ultrasound has the potential to be used as a screening tool for evaluating bowel preparation adequacy before performing the colonoscopy. To the best of the investigators' knowledge this is the first study evaluating bowel preparation by means of sonography before performing colonoscopy.

Consent will be obtained from volunteer patients who agree with participating in the study. Demographic data will be collected about an hour before the procedure. Patients will undergo transabdominal ultrasound by a trained physician 30 minutes before the scheduled colonoscopy. All the ultrasounds will be performed by one person. The sonologist will perform transabdominal ultrasound evaluation of bowel preparation using the following tools and criteria:

The scale of intestinal lumen of each section will be classified into one of four types: (i) empty (no intraluminal content is observed and the lumen is contracted or emptied; small amount of gas in colon lumen can be pressed away from the region of interest by using the transducer); (ii) filled (the lumen is filled with fluid and no obvious solid content); (iii) retention (flatulence and/or content retention in the intestine, with no improvement after pressing on the abdomen or changing the position of the patient); and (iv) mixed (two or three of the conditions described above is observed at a single site, namely filled + empty, retention + empty, retention + filled or retention + filled + empty).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

The endoscopist who performs the colonoscopy will be blinded to the ultrasound results.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adults referring for screening colonoscopy

排除标准

  • pregnancy

结局指标

主要结局

Accuracy of transabdominal ultrasound in evaluating bowel preparation adequacy before colonoscopy as assessed by the Boston Bowel Preparation Scale (BPPS)

时间窗: 4 months

The BBPS was developed to limit interobserver variability in the rating of bowel-preparation quality, while preserving the ability to distinguish various degrees of bowel cleanliness. The points are assigned as follows: * 0 - unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared. * 1 - portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. * 2 - minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well. * 3 - entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. The correlation between ultrasound score and BBPS score will be evaluated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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