Re-participation for Screening-colonoscopy - Experience of colonoscpy_1

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

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

• Written informed consent

Locations
Other Locations
Denmark
Sygehus Sønderjylland, University hospital of Southern Denmark
RECRUITING
Aabenraa
Esbjerg Hospital, University Hospital of Southern Denmark
RECRUITING
Esbjerg
Regionshospitalet Gødstrup
RECRUITING
Gødstrup
Grindsted Sygehus
RECRUITING
Grindsted
Holbæk Sygehus
RECRUITING
Holbæk
Sjællands Universitetshospital Køge
RECRUITING
Køge
Sjællands Universitetshospital, Nykøbing
RECRUITING
Nykøbing Falster
Slagelse Sygehus
RECRUITING
Slagelse
Contact Information
Primary
Magnus Ploug, phd
magnus.ploug@rsyd.dk
+45 26175029
Backup
Anitta Øhlenschlæger, Research secretary
SVS-Forskning@rsyd.dk
+45 21 33 86 07
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 8000
Related Therapeutic Areas
Sponsors
Leads: Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark

This content was sourced from clinicaltrials.gov