Prospective, Multicenter, Controlled Study on the Impact of Real-time Feedback on Red-out
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 576
- 主要终点
- Red-out percentage
研究概览
简要总结
This study will employ a prospective, multicenter, controlled design. It will be conducted across multiple centers, with participated centers randomly assigned to one of four groups: Group A, Group B, Group C, and Group D.
The research will primarily focus on the AI-based analysis of colonoscopic images to calculate the following metrics: caecal intubation time, red-out percentage, and the AI-based red-out avoiding score. Based on the study's implementation protocol, a decision will be made regarding whether to provide real-time feedback. Additionally, the presence of any complications will be assessed both during and after the colonoscopy procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Participants (Patients):
- •Aged 18 to 70 years, any gender. Individuals scheduled to undergo diagnostic or screening colonoscopy at the investigational site.
- •Colonoscopists:
- •Expert-level colonoscopists (having performed a total of >1000 colonoscopy procedures).
- •Right-handed.
排除标准
- •Study Participants (Patients):
- •Individuals undergoing the following procedures:
- •cases with a history of colorectal surgery; cases with a history of chemotherapy, raditherapy; cases with a history of abdominal, and/or pelvic surgery; cases with a history of difficult colonoscopies; cases with colorectal tumours and obstructive lesions; cases with colorectal diverticula; cases with ulcerative colitis or Crohn's disease; cases with ischemic bowel disease; cases with colorectal polyposis; cases with melanosis coli; cases undergoing sigmoidoscopy; cases with poor intestional cleanliness (segment Boston bowel preparation scale (BBPS) of < 2 points, total BBPS of < 6 points); cases undergoing therapy procedures such as biopsy or CSP during the intubation phase; cases with transparent cap assisted colonoscopy; cases with water-assisted colonoscopy; cases with air insufflation level of M or L; cases failed caecal intubation within 15 min; cases with colonoscope stiffness level > 0; obese cases or underweight cases; and cases refusing participation.
- •Individuals who decline to provide informed consent.
- •Colonoscopists:
- •Those who have performed fewer than 300 complete colonoscopies in any calendar year within the past three years.
- •Those who decline to participate in the study.
结局指标
主要结局
Red-out percentage
时间窗: Stage 3 (projected to begin in 3-6 months)
The impact of real-time feedback on red-out percentage.
Caecal intubation time
时间窗: Stage 3 (projected to begin in 3-6 months)
The impact of real-time feedback on caecal intubation time.
AI-based red-out avoiding score
时间窗: Stage 3 (projected to begin in 3-6 months)
The impact of real-time feedback on AI-based red-out avoiding score.
次要结局
- Complications(Stage 3 (projected to begin in 3-6 months))