Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 主要终点
- adenoma detection rate in the two different colonoscopies
研究概览
简要总结
The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.
详细描述
Colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in West countries. Colonoscopy is the gold standard for prevention of colorectal cancer disease. Screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. Colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. Although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. Advanced Technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. Full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population.
The investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. One arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (EndoChoice) (330º angle view)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient referred for colorectal cancer screening with positive fecal inmunological test.
- •Age between 50 and 69 years
排除标准
- •history of colonic resection,
- •high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome,
- •inflammatory bowel disease,
- •patients with lower gastrointestinal bleeding symptoms,
- •acute diverticulitis,
- •colonic strictures,
- •poor bowel preparation (Boston scale less than 5 points)
结局指标
主要结局
adenoma detection rate in the two different colonoscopies
时间窗: one week
number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period.
次要结局
- polyp detection rate in right and left colon in each group(one week)
- polyp retrieval rate in each group(one week)
- total procedure time in each group(one week)
- Adverse events(one week)
- advance adenoma rate in each group(one week)
- colonoscopy withdrawal time(one week)
- time to caecal intubation in each group(one week)
- caecal intubation rate in each group(one week)
研究者
Mª Henar Núñez Rodriguez
Dra Mª Henar Núñez Rodriguez
Hospital del Río Hortega