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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- adenoma detection rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 45-75 years
- •No colonoscopy within the past 3 years
排除标准
- •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
研究组 & 干预措施
Screening/Surveillance colonoscopy
Patients undergoing screening or surveillance colonoscopy
结局指标
主要结局
adenoma detection rate
时间窗: 2 weeks after the procedure
次要结局
- polyp detection rate(2 weeks after the procedure)
- sessile serrated lesion detection rate(2 weeks after the procedure)
- advanced adenoma detection rate(2 weeks after the procedure)
