Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The success rate of the cecal intubation within 15 min(%)
研究概览
简要总结
Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.
详细描述
Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.
Up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnostic colonoscopy;
- •Subjets able to provide informed consent
排除标准
- •Prior partial or complete colectomy;
- •Patients who decline to participate;
- •Patients with poor bowel preparation;
- •Contraindications of the colonoscopy
结局指标
主要结局
The success rate of the cecal intubation within 15 min(%)
时间窗: This will be calculated after the completion of the whole trial,which is about 2 months
次要结局
- The cecal intubation time(min);(This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length)
- The time to reach the splenic flexure(min)(This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length)
- VAS abdominal pain score(Data collected usually within 10minutes post procedure)
- The frequency of the colonoscope shortening maneuver while advancing the colonoscope(This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.)
- Length of colonoscope at time of cecal intubation(cm)(This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.)
- Volume of water used during water colonoscopy(ml)(This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.)
- General data of the patients recruited-age(Data collected usually within 10minutes post procedure .)
- General data of the patients recruited-gender(Data collected usually within 10minutes post procedure .)
- General data of the patients recruited-BMI(Data collected usually within 10minutes post procedure .)
- General data of the patients recruited-abdominal or pelvic surgery history(Data collected usually within 10minutes post procedure .)
- General data of the patients recruited-bowel preparation(Data collected usually within 10minutes post procedure .)
研究者
Youlin Yang ,MD
Professor
First Affiliated Hospital of Harbin Medical University