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临床试验/NCT07353632
NCT07353632招募中不适用

Re-participation for Screening-colonoscopy - Experience of colonoscpy_1

Esbjerg Hospital - University Hospital of Southern Denmark0 个研究点目标入组 8,000 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
8,000

研究概览

简要总结

This prospective observational study investigates how participants experience screening colonoscopy within the Danish colorectal cancer screening program and how these experiences relate to clinical findings, procedural factors, and future participation in screening.

The study aims to evaluate patient-reported experiences such as pain, discomfort, preparation burden, emotional responses, and perceptions of healthcare staff, as well as staff-assessed pain during the procedure. These experiences will be examined in relation to colonoscopy findings, including polyp detection, histology, risk stratification, and colorectal cancer detection. In addition, procedure-specific variables such as insertion time, bowel preparation quality, completeness of colonoscopy, medication use, and adenoma detection rate will be analyzed in relation to patient experience.

A key focus is whether the experience of screening colonoscopy influences subsequent participation in the colorectal cancer screening program, particularly among individuals classified as low risk and re-invited for screening after two years. Registry-based follow-up will be used to assess re-participation.

Data are collected prospectively from two sources: (1) real-time procedure data entered by healthcare staff during colonoscopy and (2) patient-reported outcomes collected via a questionnaire completed shortly after the procedure. Additional outcome data are obtained from electronic medical records and national health and screening registries.

The study has no single predefined hypothesis. Instead, it serves as a data-generating platform designed to address both predefined and future research questions related to screening colonoscopy experiences, quality indicators, and screening adherence.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults undergoing screening-derived colonoscopy as part of the Danish colorectal cancer screening program
  • Written informed consent

排除标准

  • Inability to understand or communicate in Danish
  • Lack of decision-making capacity, including cognitive impairment due to dementia or brain injury
  • Declines or withdraws informed consent

研究者

发起方
Esbjerg Hospital - University Hospital of Southern Denmark
申办方类型
Other
责任方
Sponsor

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