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

NCT07353632 | Recruiting

• 1 other identifier: 24/34903
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Pain; Colonoscopy; Screening Colonscopy

Keywords

Screening colonoscopy experience; Colorectal cancer screening; Patient-reported outcomes; Pain perception during colonoscopy; Screening re-participation

Outcome Measures

Primary Outcomes (1)

• Pain experienced during colonoscopy, reported by the patient

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

  apr. 15min after colonoscopy

Secondary Outcomes (1)

• Re-participation in screening

  2 years following colonoscopy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults undergoing a screening colonoscpy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (8)

Sygehus Sønderjylland, University hospital of Southern Denmark

Aabenraa, Denmark

RECRUITING

Esbjerg Hospital, University Hospital of Southern Denmark

Esbjerg, 6700, Denmark

RECRUITING

Grindsted Sygehus

Grindsted, 7200, Denmark

RECRUITING

Regionshospitalet Gødstrup

Gødstrup, Denmark

RECRUITING

Holbæk Sygehus

Holbæk, Denmark

RECRUITING

Sjællands Universitetshospital Køge

Køge, Denmark

RECRUITING

Sjællands Universitetshospital, Nykøbing

Nykøbing Falster, Denmark

RECRUITING

Slagelse Sygehus

Slagelse, Denmark

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Magnus Ploug, phd

CONTACT

+45 26175029; magnus.ploug@rsyd.dk

Anitta Øhlenschlæger, Research secretary

CONTACT

+45 21 33 86 07; SVS-Forskning@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: September 23, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (8)