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临床试验/NCT01554098
NCT01554098已完成4 期

A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
130
试验地点
1
主要终点
Colonic polyps

研究概览

简要总结

This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy.

Null Hypothesis:

On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position.

Alternative Hypothesis:

On withdrawal of the colonoscope, examining the patients with dynamic position change improves polyp detection compared to the supine position.

详细描述

The identification and removal of polyps has been shown to prevent bowel cancer. Although colonoscopy is the best technique to identify polyps, polyps can be missed even in expert hands. Inspection of the bowel occurs predominantly during colonoscope withdrawal. Tailoring a patients position according to the segment of bowel being examined (dynamic position change) is a technique that has been shown to improve visualisation of the bowel wall and polyp detection. However, changing patient position during colonoscope withdrawal has not been widely accepted in clinical practice. This may be because of a lack of awareness of the literature, a perception that the benefit is negligible and the inconvenience of changing a patients position in addition to the small number of publications demonstrating this to be beneficial. We plan to compare the detection of polyps when colonoscope withdrawal is done with dynamic position change (a planned series of position changes to optimise mucosal visualisation) and the supine position (laid on back). These strategies will be compared by performing a double colonoscope withdrawal; The first withdrawal will be performed either supine or in the dynamic position. This will be followed by a second insertion and withdrawal in the alternative position. The order in which these strategies are performed will be randomised i.e. supine then dynamic or dynamic then supine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Having a diagnostic colonoscopy
  • •Age >40 and <80

排除标准

  • •Inflammatory bowel disease
  • •Known polyposis syndrome
  • •Poor mobility which would limit a patients ability to turn

研究组 & 干预措施

Strategy : supine first

Active Comparator

This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.

Withdrawal in supine position followed by withdrawal with dynamic position change

干预措施: Strategy : Supine first (Procedure)

Strategy : dynamic first

Active Comparator

This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.

干预措施: Strategy : dynamic first (Procedure)

结局指标

主要结局

Colonic polyps

时间窗: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.

The primary outcome for this study is the presence or absence of polyps, detected during colonoscope withdrawal in either the supine position or with dynamic position change.

次要结局

  • Colonic polyps(Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.)
  • Luminal distension(Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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