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 University

Status: Unknown

Conditions: Quality of Life; Colonoscopy; Colorectal Neoplasms; Anxiety; Mass Screening

Treatments: Other: Real-time colonoscopic optical diagnosis for colorectal neoplasm

Study type: Interventional

Funder types: Other

Identifiers

NCT04684355

FJUH109047

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard-of-care group

No Intervention group

Description:

Participants in this group received their colonoscopic and pathological diagnosis simultaneously at next clinical visit, which arranged in 1 to 2 weeks later.

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Real-time colonoscopic optical diagnosis for colorectal neoplasm