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临床试验/NCT00460837
NCT00460837撤回4 期

Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study

London North West Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年11月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
撤回
入组人数
150
试验地点
2
主要终点
Versus standard bowel preparation

研究概览

简要总结

The study will compare patient's experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue.

详细描述

Bowel cleansing with high dose laxative is the standard bowel preparation prior to whole colon investigations but such regimens are associated with considerable patient discomfort and inconvenience, potentially affecting compliance rates [1-3].

Unlike existing whole colon investigations (conventional colonoscopy and barium enema), reduced laxative regimens can be successfully used with VC, with the aim of improving patient experience, whilst maintaining diagnostic accuracy. These regimens utilize faecal tagging; a method of labeling residual faeces and fluid with radiodense liquids, such as iodine or barium based fluids, which are taken orally by the patient. Once faecal residue and fluid is labeled in this way, it can easily be discriminated from true pathology (which remains 'untagged').

We are proposing to compare different bowel preparation regimens, and ascertain patient experience of the different regimes, while monitoring diagnostic accuracy of the 2 different regiments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • patients with symptoms attributable to colorectal cancer

排除标准

  • patients with known colorectal cancer referred for staging VC
  • patients who take laxatives regularly or with previous inadequate colonic examination due to excessive faecal residue
  • patients deemed too frail to undergo full bowel preparation

结局指标

主要结局

Versus standard bowel preparation

时间窗: 1 day (while on regimen + effectivness analysis time)

Patient experience and compliance with reduced laxative tagging versus standard preparation

时间窗: 1 day (while on regimen)

次要结局

  • Comparison of per polyp specificity between the two preparation regimens(1 day (analysis time))

研究者

申办方类型
Other

研究点 (2)

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