Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
NCT ID: NCT05125939
Last Updated: 2025-08-07
Study Results
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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RECRUITING
2700 participants
OBSERVATIONAL
2021-11-20
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Screening indication
Screening indication includes asymptomatic patients aged ≥50 years with no prior colonoscopy and at average risk of CRC. Screening indication also includes asymptomatic patients with negative prior colonoscopy.
Comparison of ADR
The investigators will compare ADRs using traditional screening-restricted definition and combined screening, surveillance, and diagnostic indication (i.e., overall-non-FIT indication). The impact of addition of FIT+ indication into the overall indication (i.e., overall-FIT indication) on ADR will also be evaluated.
Surveillance indication
Surveillance indication includes patients with prior colon neoplasms, including conventional adenomas and clinically significant serrated polyps.
Comparison of ADR
The investigators will compare ADRs using traditional screening-restricted definition and combined screening, surveillance, and diagnostic indication (i.e., overall-non-FIT indication). The impact of addition of FIT+ indication into the overall indication (i.e., overall-FIT indication) on ADR will also be evaluated.
Diagnostic indication
Diagnostic indication includes patients who report symptoms (e.g., abdominal pain, a change in bowel habits, or rectal bleeding) before their first screening examination and undergo evaluation of an abnormality on other image study, unexplained anemia and/or unexplained weight loss.
Comparison of ADR
The investigators will compare ADRs using traditional screening-restricted definition and combined screening, surveillance, and diagnostic indication (i.e., overall-non-FIT indication). The impact of addition of FIT+ indication into the overall indication (i.e., overall-FIT indication) on ADR will also be evaluated.
Positive fecal immunochemical test
FIT+ indication includes patients who undergo colonoscopy for positive FIT results in screen-eligible individuals. FIT+ indication also applies to those with a positive FIT result and a recent colonoscopy.
Comparison of ADR
The investigators will compare ADRs using traditional screening-restricted definition and combined screening, surveillance, and diagnostic indication (i.e., overall-non-FIT indication). The impact of addition of FIT+ indication into the overall indication (i.e., overall-FIT indication) on ADR will also be evaluated.
Interventions
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Comparison of ADR
The investigators will compare ADRs using traditional screening-restricted definition and combined screening, surveillance, and diagnostic indication (i.e., overall-non-FIT indication). The impact of addition of FIT+ indication into the overall indication (i.e., overall-FIT indication) on ADR will also be evaluated.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
50 Years
80 Years
ALL
No
Sponsors
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E-DA Hospital
OTHER
E-Da Dachang Hospital
UNKNOWN
Chang Gung Memorial Hospital
OTHER
Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
UNKNOWN
Evergreen General Hospital, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Chi-Liang Cheng
Role: PRINCIPAL_INVESTIGATOR
Evergreen General Hospital, Taoyuan, Taiwan
Locations
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Sepulveda Ambulatory Care Center, VAGLAHS
North Hills, California, United States
E-Da Dachang Hospital
Kaohsiung City, , Taiwan
E-Da Hospital
Kaohsiung City, , Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, , Taiwan
Evergreen General Hospital
Taoyuan District, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Kahi CJ, Vemulapalli KC, Johnson CS, Rex DK. Improving measurement of the adenoma detection rate and adenoma per colonoscopy quality metric: the Indiana University experience. Gastrointest Endosc. 2014 Mar;79(3):448-54. doi: 10.1016/j.gie.2013.10.013. Epub 2013 Nov 15.
Kaltenbach T, Gawron A, Meyer CS, Gupta S, Shergill A, Dominitz JA, Soetikno RM, Nguyen-Vu T, A Whooley M, Kahi CJ. Adenoma Detection Rate (ADR) Irrespective of Indication Is Comparable to Screening ADR: Implications for Quality Monitoring. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1883-1889.e1. doi: 10.1016/j.cgh.2021.02.028. Epub 2021 Feb 19.
Rex DK, Ponugoti PL. Calculating the adenoma detection rate in screening colonoscopies only: Is it necessary? Can it be gamed? Endoscopy. 2017 Nov;49(11):1069-1074. doi: 10.1055/s-0043-113445. Epub 2017 Jul 28.
Ladabaum U, Shepard J, Mannalithara A. Adenoma and Serrated Lesion Detection by Colonoscopy Indication: The ADR-ESS (ADR Extended to all Screening/Surveillance) Score. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1873-1882. doi: 10.1016/j.cgh.2021.04.027. Epub 2021 Apr 22.
Other Identifiers
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EGH-2022-1
Identifier Type: -
Identifier Source: org_study_id
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