跳至主要内容
临床试验/NCT03254030
NCT03254030已完成不适用

Does Careful Inspection of Colonic Mucosa During Insertion and Withdrawal During Bowel Scope Improve Rate of Adenoma Detection?

London North West Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2017年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
490
试验地点
2
主要终点
Adenoma detection rate

研究概览

简要总结

This is a prospective randomised controlled trial to assess an intervention of inspection during both phases of colonoscopic examination ( insertion and withdrawal) improve adenoma detection rate when compared to inspection only during withdrawal.

详细描述

Successful implementation of colorectal screening programmes and improvement in colonoscopic technology have resulted in significant decrease in colorectal cancer incidence and mortality. Effectiveness of colonoscopy largely depends on detection and removal of adenomas before they become cancerous. Despite the vast improvement in colonoscopy training and technology, it remains as an imperfect tool. It has been reported that the adenoma miss rate during colonoscopy varies between 6-27% in clinical practice. Adenoma Detection Rate (ADR) is a surrogate marker of efficient colonoscopy. Researchers continue to explore various methods and technologies to improve adenoma detection such as frequent position changes, routine use of antispasmodics and devices to improve the mucosal visibility (third eye retro view scope, Transparent cap, Endocuff).

However, all the techniques are focused on the withdrawal stage of the examination. Colonic examination is traditionally performed with rapid passage of colonoscope to the caecum and a careful examination of mucosa is carried out during the withdrawal phase. Polyps are removed during the withdrawal phase. It is well known from expert opinion that some polyps are detected during the insertion phase rather than withdrawal phase especially in sigmoid and transverse colon. This could be due to different anatomical configuration of colon during insertion and withdrawal.

During insertion phase colonic mucosa is stretched and the folds are splayed due to the formation of loops and angulation hence affects the visualised area of the mucosa ahead of the colonoscope. During withdrawal, the colon is shortened and the adjacent folds are brought closer to each other. On withdrawal colon is much straighter. Therefore, it may expose different portions of colonic mucosal surface on insertion and withdrawal.

Flexible sigmoidoscopy Bowel cancer screening programme (Bowel Scope) has been successfully implemented since May 2013. Initial reports suggest ADR within Bowel Scope screening varies considerably.

Therefore, we propose a simple technique to improve ADR in Bowel Scope Screening.

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
55 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who are referred for a bowel scope screening procedure

排除标准

  • Patients lacking capacity to give informed consent
  • Pregnant women
  • Age less than 55 years
  • Uncorrectable coagulopathy
  • Patients who are not fit for flexible sigmoidoscopy
  • Incomplete procedure

结局指标

主要结局

Adenoma detection rate

时间窗: 8 months

Number of participants with at least one adenoma

次要结局

  • Polyp detection rate(8 months)
  • Mean number of adenoma per patient(8 months)
  • Advanced adenoma detection rate(8 months)
  • Total procedure time(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验