A Study to Assess the Success Rate of Ultra-thin Colonoscopy Versus Conventional Colonoscopy for the First or Rescue Colonoscopy for Unsuccessful Procedures (UTC Study).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,121
- 试验地点
- 1
- 主要终点
- Successful Caecal intubation
研究概览
简要总结
The aim of the study is to study the caecal intubation rate of a prototype ultra-thin colonoscope compared to a standard colonoscope and to study usefulness of this new colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new prototype colonoscope as compared to a standard colonoscope.
详细描述
Colonoscopy is a common endoscopic procedure, widely used for the investigation of lower gastrointestinal tract diseases manifesting as altered bowel habit, per rectal bleeding and abdominal pain. It is used to diagnose colonic polyps, colorectal cancer and inflammatory bowel disease to name a few examples.
Colorectal cancer screening has been shown to decrease colorectal cancer. Despite this the uptake by the general population is suboptimal.
A new prototype colonoscope from Olympus with an additional distal bending section was designed. The investigators hypothesize that its performance characteristics will be similar to a standard colonoscope with patient tolerability.
This randomised control trial aims to invite patients attending their first outpatient colonoscopy and who are able to provide informed consent.(so they have had no prior experience) to assess the completion rate, patient and endoscopist satisfaction.
Patients with prior colorectal surgery or previous colonoscopy were excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •First outpatient colonoscopy
- •Able to provide informed consent
排除标准
- •Unable to provide consent
- •Prior colon surgery (except appendectomy)
研究组 & 干预措施
Standard Colonoscopy
Colonoscopy with standard instrument
干预措施: Standard Colonoscopy (Procedure)
Ultra-thin colonoscopy
New prototype scope
干预措施: Ultra-thin colonoscopy (Procedure)
结局指标
主要结局
Successful Caecal intubation
时间窗: 12 weeks
Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope
次要结局
- Caecal intubation time(12 weeks)
- Patient Satisfaction and Pain score(12 weeks)
- Endoscopist satisfaction(12 weeks)
研究者
James Yun-wong Lau
Professor
Chinese University of Hong Kong