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NCT Number: NCT07795788

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 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.

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Key information

Conditions

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. adenoma detection rate

    Time frame: 2 weeks after the procedure

Secondary outcomes

  1. sessile serrated lesion detection rate

    Time frame: 2 weeks after the procedure

  2. advanced adenoma detection rate

    Time frame: 2 weeks after the procedure

  3. polyp detection rate

    Time frame: 2 weeks after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Danian Ji, M.D.

CONTACT

[email protected]

+86-18019094606

Zhiyu Dong, M.D.

CONTACT

[email protected]

18817870866

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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