NCT07097350尚未招募不适用
Study on the Effect of Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- adenoma detection rate
研究概览
简要总结
A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate
详细描述
- Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: computer-aided detection alone and (2) Group 2: transparent cap-assisted computer-aided detection.
- Collecting variables which consist of primary and secodary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
排除标准
- •Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, 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
- •Patients currently enrolled in another clinical study or who participated in any clinical trial within the past 60 days
- •Insertion failure for any reason (e.g., scope cannot pass an obstruction, patient cannot tolerate the procedure) or colonoscopy not reaching the cecum
- •A Boston Bowel Preparation Scale (BBPS) score < 6 at scope insertion (inadequate preparation requiring repeat bowel cleansing)
- •Use of non-guideline-recommended bowel preparation agents
- •Patients undergoing emergency colonoscopy
结局指标
主要结局
adenoma detection rate
时间窗: 2 weeks after the procedure
次要结局
- sessile serrated lesion detection rate(2 weeks after the procedure)
- advanced adenoma detection rate(2 weeks after the procedure)
- polyp detection rate(2 weeks after the procedure)
- Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）rate(immediately after the procedure)
- Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）rate(2 weeks after the procedure)
- perforation rate(immediately after the procedure)
研究者
研究点 (1)
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