A Study to Assess the Success Rate of Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- The success rate of cecal intubation
研究概览
简要总结
The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.
详细描述
Currently there is no consensus in how to improve the success rate of colonoscopy procedure given the fact that 10% of the procedures may fail. It has been suggested that using variable stiffness colonoscope (a colonoscope with a shaft that the stiffness can be altered), or even more sophisticated magnetic imaging colonoscopy (colonoscopy performed under a magnetic position detection sensor), could improve the success rate. However, these kinds of equipment are either expensive or not always available in the daily clinical practice. From some recent studies it was shown that adding a transparent cap to the tip of the colonoscope may improve the procedure success rate without increasing the complication rate of the procedure. The cost of the cap is cheap and it is available in almost every endoscopy center. Therefore the cap-assisted colonoscopy method may be an alternative which may improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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 their first colonoscopy examination
排除标准
- •Patients had received colonoscopy examination before
- •Patients had prior colorectal surgery done (apart from appendectomy)
- •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
研究组 & 干预措施
1
Cap-assisted Colonoscopy
干预措施: Cap-assisted colonoscopy (Procedure)
2
Regular Colonoscopy
干预措施: Cap-assisted colonoscopy (Procedure)
结局指标
主要结局
The success rate of cecal intubation
时间窗: 24 hours
次要结局
- Complications related to the procedure(24 hours)
- The procedure time to achieve cecal intubation(24 hours)
- The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale(24 hours)
- Success rate in achieving terminal ileum intubation(24 hours)
- The procedure time to achieve terminal ileum intubation(24 hours)
- The procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale(24 hours)
- The patient's pain score as assessed by the patient using a visual analog scale right after he regains full consciousness, which is assessed by accurately performing a deduction test (100 minus 7 test, correct for three deductions), before discharge(24 hours)
- The dose of the intravenous drugs used(24 hours)