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Clinical Trials/NCT04684355
NCT04684355
Unknown
Not Applicable

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 University1 site in 1 country200 target enrollmentDecember 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Fu Jen Catholic University
Enrollment
200
Locations
1
Primary Endpoint
Quality of life degree
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 22, 2020
End Date
December 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chen-Ya Kuo

Attending Physician, M.D.

Fu Jen Catholic University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Quality of life degree

Time Frame: 2 weeks

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

Secondary Outcomes

  • Anxiety and depression degree(2 weeks)

Study Sites (1)

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