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临床试验/NCT01797406
NCT01797406Unknown不适用

Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Experienced Endoscopists

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年2月1日最近更新:
适应症

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

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, the investigators would conduct this study to investigate advantages of this method for experienced endoscopists.

详细描述

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 experienced endoscopists of air insufflation colonoscopy, 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

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

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 .)
  • The McGill pain evaluation of the abdominal pain(Data collected usually within 10minutes post procedure)

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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