Improving measurement of the adenoma detection rate and adenoma per colonoscopy quality metric: the Indiana University experience.
Charles J Kahi, Krishna C Vemulapalli, Cynthia S Johnson...
https://pubmed.ncbi.nlm.nih.gov/24246797Actively Recruiting
Age: 50Years - 80Years
All Genders
ID05125939
Improving Colonoscopy Adenoma Detection Metrics by Extending the Screening-only Measurement to All Indications: a Prospective Multicenter Study
Led by Evergreen General Hospital, Taiwan · Updated on 2025-08-07
2700
Participants Needed
6
Research Sites
13 weeks
Total Duration
On this page
Sponsors
E
Evergreen General Hospital, Taiwan
Lead Sponsor
E
E-DA Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether the overall adenoma detection rate (ADR) can be a reliable alternative to the screening ADR in colonoscopy procedures. This prospective multicenter study involves 18 colonoscopists from five hospitals in Taiwan and plans to recruit 2,700 participants aged 50 to 80 years over two years. The study includes patients undergoing colonoscopy for screening, surveillance, diagnostic reasons, or positive fecal immunochemical test (FIT) results. The goal is to compare ADRs across these groups and explore correlations between screening ADR and overall ADR including or excluding FIT-positive cases. Participants will be grouped based on their colonoscopy indication: screening (asymptomatic with no or negative prior colonoscopy), surveillance (with prior colon neoplasms), diagnostic (symptomatic or abnormal test findings), and FIT-positive (positive FIT results regardless of recent colonoscopy). The study will compare ADRs using traditional screening definitions and combined indications, including the impact of adding FIT-positive patients to overall ADR calculations. During the study, participants will undergo colonoscopy according to their indication. Researchers will measure the adenoma detection rate within 7 days as the primary outcome. Data collection will include categorizing patients and analyzing ADR correlations. The study will monitor participants throughout the procedure and follow-up as needed, with a total study duration of two years and study completion planned by September 2026.
CONDITIONS
Brief Title
Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
Who Can Participate
Age: 50Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Consecutive patients aged 50 years or older undergoing colonoscopy are eligible for enrollment.
You will not qualify if you...
- High risk family history of colorectal cancer, such as familial adenomatous polyposis, hereditary non-polyposis CRC syndrome, multiple first-degree relatives with CRC, or a single first-degree relative diagnosed before age 60
- Serrated polyposis syndrome
- Inflammatory bowel disease
- Colonoscopy performed to remove large neoplastic polyps
- Obstructive lesions of the colon
- Gastrointestinal bleeding
- Current participation in other studies
- Hospitalized patients
- Mental retardation
- Pregnancy
- Refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2 years
Participants undergo colonoscopy for different indications including screening, surveillance, diagnostic symptoms, or positive fecal immunochemical test (FIT+). This evaluation helps in detecting adenomas.
1 colonoscopy visit
Long-term Monitoring
Duration - Up to 2 years
Participants are observed following colonoscopy to assess adenoma detection rates across different indication categories over time.
Follow-up assessments may occur as part of routine care
Trial Site Locations
Total: 6 locations
1
Sepulveda Ambulatory Care Center, VAGLAHS
North Hills, California, United States, 91343
Active, Not Recruiting
2
E-Da Dachang Hospital
Kaohsiung City, Taiwan, 80784
Not Yet Recruiting
3
E-Da Hospital
Kaohsiung City, Taiwan, 82445
Not Yet Recruiting
4
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Not Yet Recruiting
5
Evergreen General Hospital
Taoyuan, Taiwan, 320
Actively Recruiting
6
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Not Yet Recruiting
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Research Team
C
Chi-Liang Cheng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Adenoma Detection Rate (ADR) Irrespective of Indication Is Comparable to Screening ADR: Implications for Quality Monitoring.
Tonya Kaltenbach, Andrew Gawron, Craig S Meyer...
https://pubmed.ncbi.nlm.nih.gov/33618027Calculating the adenoma detection rate in screening colonoscopies only: Is it necessary? Can it be gamed?
Douglas K Rex, Prasanna L Ponugoti
https://pubmed.ncbi.nlm.nih.gov/28753699Adenoma and Serrated Lesion Detection by Colonoscopy Indication: The ADR-ESS (ADR Extended to all Screening/Surveillance) Score.
Uri Ladabaum, John Shepard, Ajitha Mannalithara
https://pubmed.ncbi.nlm.nih.gov/33895358