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临床试验/NCT00905554
NCT00905554已完成不适用

Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial

Valduce Hospital2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
2
主要终点
Number of Patients Undergoing Complete Unsedated Colonoscopy

研究概览

简要总结

Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • adult outpatients willing to undergo colonoscopy without routine initial sedation

排除标准

  • refuse to initiate colonoscopy without routine sedation
  • inadequate bowel preparation
  • incapacity to give informed consent

结局指标

主要结局

Number of Patients Undergoing Complete Unsedated Colonoscopy

时间窗: 6-9 months

次要结局

  • Evaluation of Pain and Tolerability Scores(6-9 months)

研究者

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

Vittorio Terruzzi

MD

Valduce Hospital

研究点 (2)

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