Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision: A Randomized Controlled Study in Asia (NE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 731
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
There is no theoretical or practical reason why non-medical personnel such as nurses could not be trained to perform diagnostic colonoscopy with comparable proficiency as medical endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past 15 years as a valuable resource to cope with the increasing demand for endoscopic service, in particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists have a comparable proficiency in performing colonoscopy procedures as their medical counterparts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects receiving screening colonoscopy
- •Informed consent
排除标准
- •Subjects have undergone colonoscopy in the past 5 years
- •Patients with prior colorectal surgery
- •Subjects with a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial Adenomatous Polyposis or Familial non-polyposis syndrome
- •Pregnant or lactating women
- •Lack of consent
结局指标
主要结局
Adenoma detection rate
时间窗: Up to 3 months
次要结局
- Cecal intubation RATE(Up to 3 months)
- Withdrawal time(Up to 3 months)
- Complication rate(Up to 3 months)
- Patients pain score(Up to 3 months)
- Patients overall satisfactory score(Up to 3 months)
- Cecal intubation TIME(up to 3 months)
研究者
Aric Josun Hui
Dr
Chinese University of Hong Kong