Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Evaluation of the adenoma detection rate during screening colonoscopy
研究概览
简要总结
Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate).
Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.
This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with an indication for a screening colonoscopy.
排除标准
- •Patients under 18 years, pregnancy
- •Patients with prior colectomy or partial colectomy
- •Patients with a history of colorectal cancer
- •Patients with hereditary polyposis syndromes (FAP, HNPCC)
- •Patients with a stricture of the colon
- •Patients receiving anticoagulation prohibiting a colonoscopy
- •inability to have a patient education
- •bad conditions prohibiting a colonoscopy
结局指标
主要结局
Evaluation of the adenoma detection rate during screening colonoscopy
时间窗: Intraoperative. Adenomas detected directly during the examination.
The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy.
次要结局
未报告次要终点