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Recruiting NCT07353632

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

Observational Colonoscopy Screening Colonscopy Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colonoscopy, Screening Colonscopy, Pain. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Re-participation for Screening-colonoscopy - Experience of colonoscpy_1

Overview

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.

Primary outcome measures

  • Pain experienced during colonoscopy, reported by the patient [Time frame: apr. 15min after colonoscopy]
Secondary outcome measures (1)
  • Re-participation in screening [Time frame: 2 years following colonoscopy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 8 centers
  • Sygehus Sønderjylland, University hospital of Southern Denmark — Aabenraa
  • Esbjerg Hospital, University Hospital of Southern Denmark — Esbjerg
  • Grindsted Sygehus — Grindsted
  • Regionshospitalet Gødstrup — Gødstrup
  • Holbæk Sygehus — Holbæk
  • Sjællands Universitetshospital Køge — Køge
  • Sjællands Universitetshospital, Nykøbing — Nykøbing Falster
  • Slagelse Sygehus — Slagelse

Identifiers

NCT: NCT07353632 · 24/34903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗