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

Re-participation for Screening-colonoscopy - Experience of colonoscpy_1

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Colonoscopy; Screening Colonscopy

• Study Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Magnus Ploug, phd; Phone Number: +45 26175029; Email: magnus.ploug@rsyd.dk
• Study Contact Backup: Name: Anitta Øhlenschlæger, Research secretary; Phone Number: +45 21 33 86 07; Email: SVS-Forskning@rsyd.dk

Study Locations

• Denmark
  • Aabenraa, Denmark
    • Recruiting
    • Sygehus Sønderjylland, University hospital of Southern Denmark
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Esbjerg Hospital, University Hospital of Southern Denmark
    • Contact: Magnus Ploug, phd; Phone Number: +45 26175029; Email: magnus.ploug@rsyd.dk
  • Grindsted, Denmark, 7200
    • Recruiting
    • Grindsted Sygehus
  • Gødstrup, Denmark
    • Recruiting
    • Regionshospitalet Gødstrup
  • Holbæk, Denmark
    • Recruiting
    • Holbæk Sygehus
  • Køge, Denmark
    • Recruiting
    • Sjællands Universitetshospital Køge
  • Nykøbing Falster, Denmark
    • Recruiting
    • Sjællands Universitetshospital, Nykøbing
  • Slagelse, Denmark
    • Recruiting
    • Slagelse Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults undergoing a screening colonoscpy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-participation in screening	2-year Re-participation rate for those calssified as low risk after index colonoscopy	2 years following colonoscopy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal cancer screening; Patient-reported outcomes; Screening colonoscopy experience; Pain perception during colonoscopy; Screening re-participation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 24/34903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No