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

August 26, 2026 updated by: Zhijun Bao, Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Danian Ji, M.D.
  • Phone Number: +86-18019094606
  • Email: arctg4@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huadong Hospital, Fudan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing screening/surveillance colonoscopy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Screening/Surveillance colonoscopy
Patients undergoing screening or surveillance colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adenoma detection rate
Time Frame: 2 weeks after the procedure
2 weeks after the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
sessile serrated lesion detection rate
Time Frame: 2 weeks after the procedure
2 weeks after the procedure
advanced adenoma detection rate
Time Frame: 2 weeks after the procedure
2 weeks after the procedure
polyp detection rate
Time Frame: 2 weeks after the procedure
2 weeks after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Director: Danian Ji, M.D., Huadong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 26, 2026

First Submitted That Met QC Criteria

August 26, 2026

First Posted (Actual)

August 31, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026K353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

1 year after completion of this study

IPD Sharing Access Criteria

All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe