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临床试验/NCT04749303
NCT04749303Unknown不适用

Impact of Screen Size on Colorectal Adenoma Detection Rate: a Single Centre Randomised Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 656 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
656
试验地点
1
主要终点
Adenoma Detection Rate (ADR)

研究概览

简要总结

The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.

详细描述

Colorectal cancer is the 3rd most common cancer in the world. Recently in Hong Kong it has surpassed lung cancer to be the most common cancer. Hence it is essential not only to have up-to-date surgical and oncological treatment but also a need an effective preventative strategy.

In the past few decades, removal of pre-malignant colonic lesions such as adenomas have been shown to prevent development of colorectal cancers. Colonoscopy is currently the only technique which can perform both detection and treatment during the same procedure. However, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon. Most ICs are suspected to arise from missed colon lesions during colonoscopy. Factors concerning missed colonic lesions are multifactorial such as adequate bowel preparation, skill level of endoscopists, the number of endoscopy staff in the room as "eyes" to help with polyp detection and withdrawal time.

Following a pilot study in our endoscopy unit, we believe the size of the screen projecting the endoscopic image may have a positive influence on adenoma detection. Therefore, we feel that a well-designed and adequately powered randomised controlled trial may help to confirm this.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or above
  • Referred to the endoscopy unit for diagnostic or surveillance colonoscopy

排除标准

  • Familial history of Familial adenomatous polyposis or Hereditary non-polyposis colorectal cancer
  • Known history of inflammatory bowel disease
  • Emergency endoscopy of any nature (such as for gastrointestinal bleeding, assessment of large bowel investigation and colonic decompression)
  • Patients with colostomy
  • Previously incomplete colonoscopy (not including insufficient preparation)
  • Patients with known palliative colorectal malignant disease Patients with coagulopathies Inability to give informed consent

结局指标

主要结局

Adenoma Detection Rate (ADR)

时间窗: 12 months

ADR is defined as the proportion of an endoscopist's screening colonoscopies in which one or more adenomas have been detected in patients

次要结局

  • Severe adverse events(12 months)
  • Mean number of adenomas detected per colonoscopy(12 months)
  • Mean number of sessile serrated polyps(12 months)
  • Caecal intubation rate(12 months)
  • Bowel cleansing level(12 months)
  • Procedure Time(12 months)

研究者

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

Tony Wing Chung Mak

Clinical Associate Professor

Chinese University of Hong Kong

研究点 (1)

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