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NCT Number: NCT07353632

What Influence Re-participation in the Danish Colorectal Screening Program.

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.

Recruiting

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sygehus Sønderjylland, University hospital of Southern Denmark, Aabenraa, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Pain experienced during colonoscopy, reported by the patient

    Time frame: apr. 15min after colonoscopy

    11-point numerical rating scale ranging from 0 (least pain) to 10(most pain)

Secondary outcomes

  1. Re-participation in screening

    Time frame: 2 years following colonoscopy

    2-year Re-participation rate for those calssified as low risk after index colonoscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Anitta Øhlenschlæger, Research secretary

CONTACT

[email protected]

+45 21 33 86 07

Magnus Ploug, phd

CONTACT

[email protected]

+45 26175029

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark

Registry information

Official study title

Re-participation for Screening-colonoscopy - Experience of colonoscpy_1

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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