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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04684355
Other study ID # FJUH109047
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 22, 2020
Est. completion date December 30, 2021

Study information

Verified date December 2020
Source Fu Jen Catholic University
Contact Chen-Ya Kuo, MD
Phone +886975701515
Email b9402039@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 30, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Impaired mental status that could not understand the questionnaire questions. - Patients with major psychological disorders.

Study Design


Intervention

Other:
Real-time colonoscopic optical diagnosis for colorectal neoplasm
Colonoscopic optical diagnosis by image enhanced technology has been validated as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer.

Locations

Country Name City State
Taiwan Fu Jen Catholic University Hospital New Taipei City

Sponsors (2)

Lead Sponsor Collaborator
Fu Jen Catholic University Fu Jen Catholic University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life degree Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms. 2 weeks
Secondary Anxiety and depression degree Use Hospital Anxiety and Depression Scale (HADS) Taiwanese version to measure the anxiety and depression degree between the two study arms. 2 weeks
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