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临床试验/NCT01635725
NCT01635725已完成不适用

New Bowel Preparation Scale for Measuring the Cleansing of the Colon for Colonoscopy

Gastroenterology Services, Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Correlation coefficient between the PA and physician ratings of bowel cleanliness

研究概览

简要总结

The purpose of this investigation is validate a new bowel preparation scale and to compare it to existing bowel preparation scales.

详细描述

Early studies of bowel preparations for colonoscopy relied on scales to measure the cleanliness of the colon that were not validated or sensitive to differences in preparation quality. Often these scales would simply describe the bowel preparation as adequate or inadequate based on the endoscopist's judgment of quality of the overall preparation.

An ideal bowel cleanliness scale would:

  1. Produce a score that is reproducible from endoscopist to endoscopist (be validated).
  2. Be easy for the endoscopist to use.
  3. Produce a score that is easily converted into the poor/fair/good/excellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
  4. Produce a score that is easily converted into the adequate/inadequate subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
  5. Recognize truly outstanding preparations where 100% of the mucosa is well visualized without any cleaning required.
  6. Recognize adequate preparations (the ability to visualize the mucosa), but also measure the effort required to clean the colon of residual liquid.

In 2004, a study validating the Ottawa Preparation Scale (OPS) was published (Rostom, Jolicoeur, 2004). A description of the scoring system is below:

Ottawa Preparation Scale (OPS) rating for each colon segment 4=Inadequate (Solid stool not cleared with washing and suctioning) 3=Poor (Necessary to wash and suction to obtain a reasonable view) 2=Fair (Necessary to suction liquid to adequately view segment) 1=Good (Minimal turbid fluid in segment) 0=Excellent (Mucosal detail clearly visible) Ottawa Preparation Scale (OPS) rating for the amount of fluid in the whole colon 2=Lots of fluid

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • All Patients undergoing a colonoscopy in our office endoscopy suite

排除标准

  • Patients younger than 18 years old

结局指标

主要结局

Correlation coefficient between the PA and physician ratings of bowel cleanliness

时间窗: During a Colonoscopy (about 20 min)

The quality of the colon preparation will be graded based on the OPS, BBPS, an adequate/inadequate scale and our new CBPS. The correlation between the endoscopist's cleanliness rating and the physician assistant's cleanliness rating will be calculated using the appropriate statistical measures. These statistical measures were chosen before the study began by our statistical consultant.

次要结局

  • Correlation coefficient between the PA and physician ratings of total bowel fluid.(During a Colonoscopy (about 20 min))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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