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临床试验/NCT02305251
NCT02305251已完成不适用

Patient Preferences of a Resect and Discard Paradigm

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年6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
500
试验地点
1
主要终点
Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found.

研究概览

简要总结

The investigators conducted a study "Resect and Discard Diminutive Polyps: a new paradigm" (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors performing colonoscopy are accurate enough at predicting histology of small colorectal polyps, such that these small polyps could be resected and discarded (instead of being sent to pathology). One of the main advantages of this approach is significant cost savings by reducing pathology costs associated with screening and surveillance colonoscopy. A disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no data regarding patient preferences toward this approach. The investigators therefore designed a patient survey to determine the patient's view toward this approach.

详细描述

The American Society of Gastrointestinal Endoscopy (ASGE) published a review article on a new paradigm in colorectal cancer screening termed "resect and discard". This new paradigm challenges the current practice of sending all colorectal polyps, regardless of appearance or size, to pathology for analysis. "Resect and Discard" describes a new approach in which small polyps could be removed, but be discarded instead of sent for pathology analysis. This is based on data showing that gastroenterologists can predict the pathology of small colorectal polyps with 80-90% accuracy, and that discarding small polyps would not alter surveillance recommendations.

Neither the ASGE document nor published research, however, assessed patient attitudes toward this approach. This study surveyed patients prior to first time screening colonoscopy, in order to determine their preferences about the resect and discard approach; specifically would patients be willing to pay for pathology analysis of small colorectal polyps with their own money, and what factors influence their decision. We also inquired about factors that would influence their decision to pay/not pay pathology costs themselves.

研究设计

研究类型
Observational
观察模型
Other
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

  • Indication for colonoscopy is screening or routine polyp surveillance

排除标准

  • Indication for colonoscopy other than screening or surveillance
  • Colon cancer identified at time of colonoscopy
  • Known polyposis syndrome, or polyposis identified at colonoscopy

结局指标

主要结局

Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found.

时间窗: June, 2012 to March, 2014: up to 2 years

This outcome is measured in percentage.

次要结局

  • The factors that influence patients' decisions to pay or not pay for pathology costs with their own money.(June, 2012 to March, 2014: up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dayna Early

Professor of Medicine

Washington University School of Medicine

研究点 (1)

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