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临床试验/NCT02552017
NCT02552017Unknown不适用

Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

South Tyneside and Sunderland NHS Foundation Trust14 个研究点 分布在 1 个国家目标入组 1,772 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,772
试验地点
14
主要终点
Adenoma detection rate

研究概览

简要总结

The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

详细描述

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • All patients referred for screening, surveillance, or diagnostic colonoscopy
  • All patients must be able to give informed consent

排除标准

  • Patients with any absolute contraindications to colonoscopy
  • Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
  • Patients with known colon cancer or polyposis syndromes
  • Patients with known colonic strictures
  • Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
  • Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  • Patients lacking capacity to give informed consent
  • Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
  • Patients who are attending for a therapeutic procedure or assessment of a known lesion

结局指标

主要结局

Adenoma detection rate

时间窗: 10 months

A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.

次要结局

  • Mean adenomas detected per procedure(10 months)
  • Rate of cuff exchange(10 months)
  • Effect on duration of caecal intubation rates(10 months)
  • Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires(10 months)
  • Increase in surveillance colonoscopies caused by increased adenoma detection rate(10 months)
  • Number of proximal sessile serrated polyps by histology(10 months)
  • Polyp location(10 months)
  • Adenoma detection rate of BCSP and non-BCSP endoscopists(10 months)
  • Change in adenoma detection rate of each endoscopist during the course of the trial(10 months)
  • Adenoma detection rate of individual endoscopist before and after trial commencement(10 months)

研究者

发起方
South Tyneside and Sunderland NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (14)

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