Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 2
研究概览
简要总结
Colorectal cancer is one of the most frequent and it prognosis is still serious. In France, diagnosis and screening applicated in numerous departements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Haemoccult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitute an invasive method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasive method is required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years
- •patient able to give his informed consent
- •No colorectal, intestinal inflammatory, ischemic or evolving infectious pathologies
- •No signs of stenosis of small intestine or colon
- •No contraindication to anesthesia
- •No participation to an other clinical study
- •Patient with and indication to colonoscopy for searching of a colorectal neoplasia during a screening program OR
- •Patient for who a endoscopic following is required because of familial cases or personal cases of polyps or colorectal cancer
排除标准
- •Presence of symptoms evocating an occlusive pathology
- •Recent complicated colic diverticulosis
- •No informed consent
- •pregnancy or no use of efficient contraception treatment
- •Patient with a pace-maker or others internal medical electronic device
- •Evolved nephric or cardiac insufficiencies
- •Hypersensibility to Fleet Phospho Soda (or one of the excipient), bisacodyl (or one of the excipient), motilium (or one of the excipient)
- •Presence of a prolactinoma
