Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 692
- 试验地点
- 2
- 主要终点
- Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
研究概览
简要总结
Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.
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
- •Subjects participating in the Colorectal cancer Screening program with faecal immunological test > 100ng / ml.
- •Ages between 50-69 years.
- •Adequate preparation according to the Boston scale: in right colon (score> 2 in this section)
- •Informed consent.
排除标准
- •Refusal to give informed consent.
- •Subjects with elevated colorectal cancer risk due to family history or inherited diseases of polyposis or inflammatory bowel disease
- •Symptomatic subjects.
- •Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration
- •Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right colon)
结局指标
主要结局
Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
时间窗: through study completion, an average of 1 year
Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool
次要结局
- Second look for right colon improve adenoma detection rate(through study completion, an average of 1 year)
- Rate of retroflexion related adverse events(through study completion, an average of 1 year)
- Rate of retroflexion proximal adverse events with a pediatric colonoscopy(through study completion, an average of 1 year)
- Pre-procedure factors(through study completion, an average of 1 year)
研究者
Mª Henar Núñez Rodriguez
Principal Investigator: Dra Mª Henar Núñez Rodriguez
Hospital del Río Hortega