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临床试验/NCT02057562
NCT02057562Unknown不适用

Impact of Diverticular Disease on the Detection of Colon Adenomas

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
2
主要终点
Adenoma detection rate

研究概览

简要总结

Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. The same epidemiological pattern can be found with regard to colon diverticula. Furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. It is not known whether a correlation exists between both entities. Some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. The investigators therefore plan to conduct the following trial.

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

入选标准

  • indication for colonoscopy
  • age >= 18 years

排除标准

  • pregnant women
  • patients denying written consent
  • indication for colonoscopy: familial adenomatous polypose
  • indication for colonoscopy: inflammatory bowel disease
  • indication for colonoscopy: previously known colon polyp/adenoma/carcinoma
  • history of colon surgery
  • contraindication for resection of polyps
  • American Society of Anesthesiologists (ASA) class IV, V or VI

结局指标

主要结局

Adenoma detection rate

时间窗: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)

After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined

次要结局

  • Polyp detection rate(up to one day)
  • Frequency of colon diverticulosis(up to one day)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Peter Klare

MD

Technical University of Munich

研究点 (2)

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