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Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate

Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate: A Single-Center, Prospective, Observational Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07795788
Enrollment
560
Registered
2026-08-31
Start date
2026-10-01
Completion date
2027-12-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenoma

Keywords

adenoma detection rate, Bowel preparation assessment, Artificial intelligence

Brief summary

A single-center prospective observational study evaluates the correlation between an AI-based bowel preparation quality score (FQ-BBPS\[25%\]), which quantifies fecal coverage area during colonoscopy withdrawal, and the adenoma detection rate (ADR) in screening/surveillance patients.

Detailed description

The FQ-BBPS system uses image segmentation to automatically calculate the percentage of mucosa obscured by feces/fluid, providing a continuous, objective alternative to the conventional Boston Bowel Preparation Scale (BBPS). Preliminary retrospective data showed a strong correlation (Spearman ρ = -0.829) between FQ-BBPS(25%) and ADR, and adding this metric improved adenoma prediction over e-BBPS alone. This prospective study (October 2026 - September 2027) will consecutively enroll patients aged 45-75 years undergoing colonoscopy for screening or polyp surveillance, excluding those with prior colorectal surgery, cancer, alarm symptoms, anticoagulant use, or recent trial participation. With a conservative assumed correlation of -0.70, a sample size of 560 (allowing 10% dropout) is planned. The primary outcome is ADR (proportion with ≥1 histologically confirmed adenoma), and secondary outcomes include detection rates for serrated lesions, advanced adenomas, and polyp detection by size/location; safety endpoints (perforation, immediate/delayed bleeding) will also be recorded. The FQ-BBPS(25%) score will be computed automatically from withdrawal videos, while endoscopists record BBPS and polyp characteristics. Spearman correlation will assess the association, and ROC analysis will explore the optimal cutoff against the 35% ADR reference. The study adheres to the Declaration of Helsinki, with ethics approval and written informed consent from all participants.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* aged 45-75 years * No colonoscopy within the past 3 years

Exclusion criteria

* Patients scheduled for therapeutic colonoscopy, postoperative surveillance after colorectal surgery, or treatment of histologically confirmed polyps * Patients with highly suspected or pathologically confirmed colorectal cancer * Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination) * Pregnant or breastfeeding women * Patients with gastrointestinal obstruction * Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome * Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders * Failed cecal intubation due to any cause other than excessive feces preventing intubation (e.g., obstructive lesions preventing scope passage, or patient intolerance to the procedure). * Use of non-guideline-recommended bowel preparation agents * Patients undergoing emergency colonoscopy

Design outcomes

Primary

MeasureTime frame
adenoma detection rate2 weeks after the procedure

Secondary

MeasureTime frame
sessile serrated lesion detection rate2 weeks after the procedure
advanced adenoma detection rate2 weeks after the procedure
polyp detection rate2 weeks after the procedure

Countries

China

Contacts

CONTACTDanian Ji, M.D.
arctg4@163.com+86-18019094606
CONTACTZhiyu Dong, M.D.
18817870866@163.com18817870866
STUDY_DIRECTORDanian Ji, M.D.

Huadong Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026