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NCT05125939Recruiting

Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study

Evergreen General Hospital, Taiwan

Start Date

11/20/2021

Completion Date

9/30/2026

Summary

This is a prospective equivalence colonoscopy study evaluating whether overall adenoma detection rate (ADR) is a reliable alternate for screening ADR. Overall indication includes screening, surveillance, and diagnostic indications.

Detailed Description

This multicenter study will be conducted by 18 colonoscopists from 5 hospitals in Taiwan, including Evergreen general hospital, E-da hospital, E-da Dachang hospital, Linkou Chang Gung memorial hospital, and Keelung Chang Gung memorial hospital, and plans to recruit 2700 prospective participants in a 2-year period. Felix W. Leung from Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System (USA) will be involved in the study design, and will participate in data analyses and report preparation. Consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment. Positive fecal immunochemical test (FIT+) is considered as an independent indication category and the colonoscopy indications are categorized into 4 groups: screening, surveillance, diagnostic, and FIT+. Overall indication will be subdivided into overall excluding FIT (overall-non-FIT) group and overall including FIT (overall-FIT) group. In this study, the investigators plan to (1) compare individual ADR across 4 colonoscopy indication categories (screening, surveillance, diagnostic, FIT+); (2) explore correlations between screening ADR and overall-non-FIT and overall-FIT ADRs, respectively.

Eligibility Criteria

Age Range: 50 years to 80 years

Inclusion Criteria: * consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment. Exclusion Criteria: * high risk family history of colorectal cancer (CRC) e.g., familial adenomatous polyposis, hereditary non-polyposis CRC syndrome, multiple first degree relatives with CRC, or a single first degree relative with CRC at \<60 years * serrated polyposis syndrome * inflammatory bowel disease * colonoscopy to remove a large neoplastic polyps * obstructive lesions of the colon * gastrointestinal bleeding * current participation in other studies * hospitalized patients * mental retardation * pregnancy * refusal to provide a written informed consent.

Interventions

OTHER

Comparison of ADR

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Conditions

Adenoma Detection RateColonoscopy

Locations

Sepulveda Ambulatory Care Center, VAGLAHS

North Hills, California 91343

United States

E-Da Dachang Hospital

Kaohsiung City, 80784

Taiwan

E-Da Hospital

Kaohsiung City, 82445

Taiwan

Keelung Chang Gung Memorial Hospital

Keelung, 204

Taiwan

Evergreen General Hospital

Taoyuan, 320

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan