Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Success of colonoscopy
研究概览
简要总结
In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:
- Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
- Study method improves bowel preparation and increases polyp pickup rate
详细描述
Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.
The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.
In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>50 years old)
- •Male and female patients
- •Scheduled and consented for screening or surveillance colonoscopy without medications
- •Accept randomization to the study or the conventional method
- •Agree to complete study questionnaires
- •The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.
排除标准
- •Patients who decline to participate
- •Unable to give informed consent or complete the questionnaires due to language or other difficulties
研究组 & 干预措施
Water method
Water infusion in lieu of air insufflation for screening and surveillance colonoscopy
干预措施: Water infusion in lieu of air insufflation (Procedure)
Air method
Air insufflation for screening and surveillance colonoscopy
干预措施: Air method (Procedure)
结局指标
主要结局
Success of colonoscopy
时间窗: 24 months
successful cecal intubation
次要结局
- Polyp detection(24 months)
