Detection of Adenomas in Screening Colonoscopy - Endocuff Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Adenoma Colon
- 发起方
- Herning Hospital
- 入组人数
- 1178
- 试验地点
- 1
- 主要终点
- adenoma
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.
详细描述
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds. The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer. This study is a randomized controlled trial with 900 patients.
研究者
Claudia Jaensch
principan investigator
Herning Hospital
入排标准
入选标准
- •all Citizens participating in the national bowel screening program
排除标准
- •persons who are disabled and who do not understand the Danish language
- •persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection
- •persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan.
- •persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve
结局指标
主要结局
adenoma
时间窗: 2 weeks
number of adenomas found during colonoscopy
次要结局
- cecal intubation time(up to 2 hours)
- cecal intubation rate(up to 2 hours)
- adenoma size(up to 4 weeks)
- withdrawal time(up to 60 minutes)
- adenoma site(up to 4 weeks)