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临床试验/NCT02978664
NCT02978664已完成不适用

The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange

Dalin Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年10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
500
试验地点
1
主要终点
adenoma detection rate

研究概览

简要总结

The investigators will review video-recordings of three randomized, controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi Hospital.

详细描述

The investigators will review video-recordings of three randomized controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be obtained from the local Institutional Review Board (IRB) to review, analyze and report de-identified findings.

Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies. Recordings will be selected for review if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection will be excluded from analysis. The included video recordings will be edited to remove the insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer uninvolved in the performance of the colonoscopies will be in charge of evaluating the selected videos, using the criteria described by Yung et al

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers.

排除标准

  • •Patients with incomplete recordings and a history of bowel resection will be excluded from analysis.

研究组 & 干预措施

water immersion

Active Comparator

Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy

干预措施: water immersion (Procedure)

water exchange

Active Comparator

Water will be infused and removed during insertion phase of colonoscopy

干预措施: Water exchange (Procedure)

Air insufflation

Active Comparator

Air insufflation will be used throughout whole procedure of colonoscopy

干预措施: Air insufflation (Procedure)

结局指标

主要结局

adenoma detection rate

时间窗: one week after colonoscopy

次要结局

  • Distraction score(Immediate after video reviewing)
  • Withdrawal technique as specified by Lee RH (citation 1)(immediate after video reviewing)
  • Bowel preparation score(immediate after video reviewing)

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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