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临床试验/NCT01761097
NCT01761097Unknown不适用

A Pilot Study to Assess the Role for Endocuff© Assisted Colonoscopy in the Detection of Colonic Cancer and Polyps

Cambridge University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Proportion of patients with adenomas and cancers detected

研究概览

简要总结

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon.

The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.

The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.
  • Ability to understand the nature and requirements of the study and to provide written informed consent.

排除标准

  • Contraindication to undergo standard colonoscopy.
  • Severe active colitis.
  • Known colonic stricture

结局指标

主要结局

Proportion of patients with adenomas and cancers detected

时间窗: immediate

次要结局

  • Caecal intubation time(Immediate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rob Mead

Dr. R.J.Mead

Cambridge University Hospitals NHS Foundation Trust

研究点 (2)

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