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

Not Applicable

• Conditions: Colonoscopy; Anxiety; Colorectal Neoplasms; Quality of Life; Mass Screening
• Interventions: Other: Real-time colonoscopic optical diagnosis for colorectal neoplasm

• Registration Number: NCT04684355
• Lead Sponsor: Fu Jen Catholic University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-21
• Study Start: 2020-12-22
• Study First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24
• Primary Completion: 2021-08-31
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Real-time colonoscopic optical diagnosis for colorectal neoplasm	Participants in this group received their colonoscopic diagnosis right after they awake from general anesthesia, and then received pathological diagnosis at next clinical visit, which arranged in 1 to 2 weeks later.

Primary Outcome Measures

Name	Time	Method
Quality of life degree	2 weeks	Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression degree	2 weeks	Use Hospital Anxiety and Depression Scale (HADS) Taiwanese version to measure the anxiety and depression degree between the two study arms.

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital; 🇨🇳 New Taipei City, Taiwan