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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

NCT ID: NCT04684355

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2021-12-30

Brief Summary

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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

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Conditions

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Colorectal Neoplasms Colonoscopy Quality of Life Mass Screening Anxiety

Keywords

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Colorectal Neoplasms Colonoscopy Quality of Life Mass Screening Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Real-time colonoscopic optical diagnosis for colorectal neoplasm

Intervention Type OTHER

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.

Standard-of-care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University Hospital

OTHER

Sponsor Role collaborator

Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Chen-Ya Kuo

Attending Physician, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fu Jen Catholic University Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chen-Ya Kuo, MD

Role: CONTACT

Phone: +886975701515

Email: [email protected]

Facility Contacts

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Chen-Ya Kuo, MD

Role: primary

Other Identifiers

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FJUH109047

Identifier Type: -

Identifier Source: org_study_id