Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The success rate of cecal intubation
研究概览
简要总结
The aim of this prospective randomized controlled trial is to assess the efficacy of cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy for trainees.
详细描述
Colorectal cancer is one of the major malignancies in western countries and also in Japan. Therefore , the demand for total colonoscopy (TCS) has risen remarkably. However, failure to reach the cecum occurs in up to 10 % of cases.
A difficult colonoscopy procedure will often be associated with more complications, and require heavier sedation to alleviate patient's discomfort.
Auxiliary devices that could facilitate the examination would be needed. A cap is a simple device that can be attached to the tip of a colonoscope. The advantage of the cap in getting a good view might be helpful in cecal intubation by depressing the folds and also by keeping an appropriate distance between the colonoscope lens and colonic mucosa. We speculated that inexperienced colonoscopists would obtain greater benefit from cap-attached 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
- Double (Participant, Outcomes Assessor)
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
- •Patients who undergo colonoscopy examination
排除标准
- •Known to have colonic stricture or obstructing tumor from the results of other investigations such as CT scan or barium enema
- •Presence of acute surgical conditions such as severe colitis, megacolon, ischemic colitis and active gastrointestinal bleeding ・ Patients who diagnosed as inflammatory bowel disease
研究组 & 干预措施
Cap-attached Colonoscopy
干预措施: Cap-attached Colonoscopy Versus Regular Colonoscopy (Device)
Regular colonoscopy
干预措施: Cap-attached Colonoscopy Versus Regular Colonoscopy (Device)
结局指标
主要结局
The success rate of cecal intubation
时间窗: 24 hours
次要结局
- The polyp detection rate(24 hours)
- The procedure time to achieve cecal intubation(24 hours)
- The procedure time to achieve terminal ileum intubation(24 hours)
- The dose of the intravenous drugs used(24 hours)
- Success rate in achieving terminal ileum intubation(24 hours)
- Complications related to the procedure(24 hours)
研究者
Makoto Kutsukawa
Researcher
Showa University