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临床试验/NCT04684355
NCT04684355Unknown不适用

Quality of Life of Colorectal Cancer Screenees in the Period Between Colonoscopy and Next Clinic Visit for Final Report: Does Real-time Endoscopic Optical Diagnosis Improve Their Quality of Life

Fu Jen Catholic University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Quality of life degree

研究概览

简要总结

Colorectal cancer screening program has been proven to reduce colorectal cancer (CRC) mortality and is cost-effective. It has been adopted by most countries in the world, and colonoscopy is regarded as the most accurate test for detecting colorectal neoplasm. After screenees underwent colonoscopy, most endoscopists do not routinely explain the preliminary optical diagnosis to the subjects before they going home, which may cause unnecessary anxiety and may reduce the quality of life of the subjects before acquiring the final results. In recent years, endoscopic optical diagnostic technology has been validated by meta-analysis studies as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer. The real time feature of endoscopic optical diagnosis allows endoscopists to explain the preliminary results confidently to the subjects immediately after colonoscopy, which is expected to reduce the anxiety of the subjects before they acquired the final results and improve their quality of life. We designed a randomized controlled trial to validate whether real-time endoscopic optical diagnosis could decrease the anxiety burden and improve the quality of life for colorectal-cancer screenees after colonoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who preparing to received screening or surveillance colonoscopy under general anesthesia.
  • Patients who preparing to received sedated colonoscopy due to other GI tract related symptoms.

排除标准

  • Impaired mental status that could not understand the questionnaire questions.
  • Patients with major psychological disorders.

结局指标

主要结局

Quality of life degree

时间窗: 2 weeks

Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.

次要结局

  • Anxiety and depression degree(2 weeks)

研究者

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

Chen-Ya Kuo

Attending Physician, M.D.

Fu Jen Catholic University

研究点 (2)

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