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临床试验/NCT01547247
NCT01547247已完成不适用

Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Vitkovice Hospital2 个研究点 分布在 2 个国家目标入组 208 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
208
试验地点
2
主要终点
Cecal Intubation Time

研究概览

简要总结

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.

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
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

入选标准

  • outpatient diagnostic colonoscopy
  • bowel prep with macrogolum
  • initial 2 mg of midazolam i.v.
  • signed informed consent form

排除标准

  • planned therapeutic intervention
  • colorectal surgery in history
  • known inflammatory bowel disease or colorectal cancer
  • refusal of sedation

研究组 & 干预措施

cap-assisted water immersion colonoscopy

Experimental

Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

干预措施: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope (Device)

water immersion colonoscopy

Active Comparator

Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

干预措施: water immersion colonoscopy (Procedure)

结局指标

主要结局

Cecal Intubation Time

时间窗: 3 months

The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.

次要结局

  • Patient Comfort During Insertion Phase of the Colonoscopy(3 months)
  • Success Rate of Minimal Sedation Colonoscopy(3 months)

研究者

发起方
Vitkovice Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Premysl Falt MD

Principal Investigator

Vitkovice Hospital

研究点 (2)

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