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临床试验/NCT04307901
NCT04307901招募中不适用

Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
Complete mucosal visualization combining incomplete investigations

研究概览

简要总结

Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps >9 mm and polyps >5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.

Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.

排除标准

  • Chrohn's disease with symptoms of stenosis and/or pacemaker

结局指标

主要结局

Complete mucosal visualization combining incomplete investigations

时间窗: 10 years

By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.

次要结局

  • Completion rate of colon capsule endoscopy(2 years)
  • Economic evaluation(1 year)
  • Safety of colon capsule endoscopy(1 year)
  • Quality of colon capsule endoscopy(1 year)
  • Patient preference(2 years)

研究者

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

Issam al-Najami

Principal Investigator

Odense University Hospital

研究点 (1)

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