NCT07353632 What Influence Re-participation in the Danish Colorectal Screening Program.
| NCT ID | NCT07353632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark |
| Condition | Colonoscopy |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,000 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8,000 participants in total. It began in 2024-09-23 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07353632 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Colonoscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07353632 currently recruiting?
Yes, NCT07353632 is actively recruiting participants. Contact the research team at magnus.ploug@rsyd.dk for enrollment information.
Where is the NCT07353632 trial being conducted?
This trial is being conducted at Aabenraa, Denmark, Esbjerg, Denmark, Grindsted, Denmark, Gødstrup, Denmark and 4 additional locations.
Who is sponsoring the NCT07353632 clinical trial?
NCT07353632 is sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. The trial plans to enroll 8,000 participants.