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临床试验/NCT01633333
NCT01633333已完成不适用

Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

Sorlandet Hospital HF4 个研究点 分布在 2 个国家目标入组 473 人开始时间: 2012年6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
473
试验地点
4
主要终点
Pain during colonoscopy

研究概览

简要总结

Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.

详细描述

Single blinded randomized controlled trial.

研究设计

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

入排标准

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

入选标准

  • Patients scheduled for screening or polyp surveillance colonoscopy
  • Patients accepting sedation on demand

排除标准

  • Demand for sedation/analgesia before the start of the procedure
  • Previous partial or total colonic resection
  • Pregnancy
  • Unwilling/unable to provide informed consent

结局指标

主要结局

Pain during colonoscopy

时间窗: 1 hour

Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.

次要结局

  • Pain during colonoscopy(30 minutes)
  • Cecal intubation rate(1 hour)
  • Cecal intubation time(1 hour)
  • Adenoma detection rate(1 hour)
  • Polyp detection rate(1 hour)
  • Dose of medication(1 hour)

研究者

发起方
Sorlandet Hospital HF
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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