ColonoscopyNCT07353632
What Influence Re-participation in the Danish Colorectal Screening Program.
An observational study of Colonoscopy and Screening Colonscopy, run by Esbjerg Hospital - University Hospital of Southern Denmark at 8 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colonoscopy, Screening Colonscopy, Pain
- How many people
- 8,000 participants
- Where
- 8 sitesDenmark
- Study dates
- 23 Sep 2024to 30 Jun 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing a screening colonoscpy
Who may be able to join
- Adults undergoing screening-derived colonoscopy as part of the Danish colorectal cancer screening program
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Denmark8 sites, 8 recruiting
- Recruiting
Sygehus Sønderjylland, University hospital of Southern Denmark
Aabenraa
- Recruiting
Esbjerg Hospital, University Hospital of Southern Denmark
Esbjerg, 6700
Magnus Ploug, phd, +45 26175029, magnus.ploug@rsyd.dk
- Recruiting
Regionshospitalet Gødstrup
Gødstrup
- Recruiting
Grindsted Sygehus
Grindsted, 7200
- Recruiting
Holbæk Sygehus
Holbæk
- Recruiting
Sjællands Universitetshospital Køge
Køge
- Recruiting
Sjællands Universitetshospital, Nykøbing
Nykøbing Falster
- Recruiting
Slagelse Sygehus
Slagelse
About this study
Official title: 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.
Read more
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
- Colonoscopy, Screening Colonscopy, Pain
- Keywords
- Screening colonoscopy experience, Colorectal cancer screening, Patient-reported outcomes, Pain perception during colonoscopy, Screening re-participation
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experienced during colonoscopy, reported by the patient
11-point numerical rating scale ranging from 0 (least pain) to 10(most pain)
Measured: apr. 15min after colonoscopy
Secondary outcomes (1)
Re-participation in screening
2-year Re-participation rate for those calssified as low risk after index colonoscopy
Measured: 2 years following colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start23 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353632
- Sponsor's protocol ID
- 24/34903
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-participation for Screening-colonoscopy - Experience of colonoscpy_1
- ClinicalTrials.gov ID
- NCT07353632
- Acronym / sponsor ID
- 24/34903
- Conditions
- Colonoscopy, Screening Colonscopy, Pain
- Keywords
- Screening colonoscopy experience, Colorectal cancer screening, Patient-reported outcomes, Pain perception during colonoscopy, Screening re-participation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing a screening colonoscpy
Key inclusion criteria (2 listed)
- Adults undergoing screening-derived colonoscopy as part of the Danish colorectal cancer screening program
- Written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain experienced during colonoscopy, reported by the patient
Time frame: apr. 15min after colonoscopy
11-point numerical rating scale ranging from 0 (least pain) to 10(most pain)
1 secondary outcome
Re-participation in screening
Time frame: 2 years following colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Screening Colonscopy, run by Esbjerg Hospital - University Hospital of Southern Denmark at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Ploug, phd (+45 26175029, magnus.ploug@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain experienced during colonoscopy, reported by the patient (time frame: apr. 15min after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.