Colorectal CancerNCT04862793
Computerized Feedback in Colonoscopy
A study testing Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS) in people with Colorectal Cancer and Healthy, run by Copenhagen Academy for Medical Education and Simulation.
Trial summary
In a cluster-randomized study compare if feedback from two computerized feedback systems doing a colonoscopy (CoPS and CoRS) can improve the adenoma detection rate and decrease patient discomfort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Healthy
- What is being tested?
- Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admitted for a screening colonoscopy through the Danish National Screening Program for Colorectal Cancer.
Who cannot join
- In cases were the cecum is not reached.
- Unsatisfactory bowel preparation which results in admission for a new procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Computerized Feedback During Colonoscopy on Adenoma Detection Rate of Colorectal Cancer and Patient Related Satisfaction: A Cluster-randomized Controlled Trial.
In a cluster-randomized study compare if feedback from two computerized feedback systems doing a colonoscopy (CoPS and CoRS) can improve the adenoma detection rate and decrease patient discomfort.
Read the detailed description
Background:
Approximately 4,600 persons get colon cancer annually in Denmark and it is the second most common cause of cancer death. Survival is highly dependent on early detection through a colonoscopy. A thorough colonoscopy is essential to detect early cancers but unfortunately the quality of colonoscopies varies widely between operators. A study of 314,872 colonoscopies performed by 136 gastroenterologists found that the adenoma detection rate (ADR) ranged from 7 - 53% and was inversely associated with the risks of fatal interval cancer. The investigators have developed to tools that can generate automatic, computerized feedback in order to make a more thorough procedure and reduce patient discomfort, the Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS)
Objectives:
The investigators predict that live-feedback from CoPS and CoRS doing a colonoscopy can improve the ADR and subsequent prevent colorectal cancer. The aim of this project is to:
- In a cluster-randomized study compare if feedback from CoPS and CoRS can improve the adenoma detection rate and patient satisfaction for individual operators and the department as a whole.
- Make an immediate measure to assess the quality of individual colonoscopy performance.
Materials and methodology:
As a randomized controlled cluster trial following a stepped-wedge program, feedback doing a colonoscopy from these (CoPS and CoRS) will be tested compared to no feedback. Three test departments consisting of three University Hospital in the Capital region of Denmark will be included.
- Conditions
- Colorectal Cancer, Healthy
- Being tested
- Colonoscopy Progression Score (CoPS), Colonoscopy Retraction Score (CoRS)
- Keywords
- Colonoscopy, Adenoma Detection Rate, Computerized Feedback
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy Progression Score (CoPS)Device
The Colonoscopy Progression Score consists of five different aspects: Travel length, Tip progression, chase efficiency, shaft movement without tip progression and looping.
Colonoscopy Retraction Score (CoRS)Device
The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Experimental | Feedback system through CoPS and CoRS Receives: Device: Colonoscopy Progression Score (CoPS); Device: Colonoscopy Retraction Score (CoRS) |
| Standard procedure | No intervention | Performing the standard procedure in accordance with the departments usual conduct. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole.
The Adenoma Detection Rate of an operator is correlated to patient survival of colorectal cancer. A low Adenoma Detection Rate is correlated with a higher occurrence of interval cancer. Increasing the Adenoma Detection Rate will result in a more beneficial screening program with more cancers being caught in an earlier state and thereby increase patient survival.
Measured: Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.
Feedback from CoPS results in change in patient discomfort.
Patient discomfort will be assessed by a post-procedure questionnaire. We will examine the correlation between the intervention and patient discomfort, and assess if more procedures can be completed due to less patient discomfort using the intervention.
Measured: Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.
Secondary outcomes (1)
Make an immediate measure to assess the quality of individual colonoscopy performance.
To measure a reliable Adenoma detection rate, 500 procedures are needed. We will aim to make an immediate measure based on CoRS to assess the quality of each colonoscopy and investigate this measures correlation to the ADR in the intervention period.
Measured: On data collection completion, estimated December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study startJun 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled cluster trial following a stepped-wedge randomization.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Ambu A/S, Region Capital Denmark, Herlev Hospital, Bispebjerg Hospital, Hillerod Hospital, Denmark
- Responsible party
- Principal investigator, Kristoffer Mazanti Cold, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Kristoffer Mazanti Cold, MD, Principal investigator, PhD-alumni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862793
- Sponsor's protocol ID
- P-2021-256
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Cold KM, Vamadevan A, Heen A, Vilamann AS, Rasmussen M, Svendsen MBS, Konge L. Effect of a computer-aided quality feedback system on colonoscopists' adenoma detection rate in Denmark: a multicentre, stepped-wedge, cluster-randomised, controlled trial. Lancet Digit Health. 2026 Sep 2:101046. doi: 10.1016/j.landig.2026.101046. Online ahead of print.
PubMed 42686507
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computerized Feedback During Colonoscopy on Adenoma Detection Rate of Colorectal Cancer and Patient Related Satisfaction: A Cluster-randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04862793
- Acronym / sponsor ID
- P-2021-256
- Conditions
- Colorectal Cancer, Healthy
- Keywords
- Colonoscopy, Adenoma Detection Rate, Computerized Feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Ambu A/S, Region Capital Denmark, Herlev Hospital, Bispebjerg Hospital, Hillerod Hospital, Denmark
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Apr 2021 (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.
In a cluster-randomized study compare if feedback from two computerized feedback systems doing a colonoscopy (CoPS and CoRS) can improve the adenoma detection rate and decrease patient discomfort.
Detailed description
Background:
Approximately 4,600 persons get colon cancer annually in Denmark and it is the second most common cause of cancer death. Survival is highly dependent on early detection through a colonoscopy. A thorough colonoscopy is essential to detect early cancers but unfortunately the quality of colonoscopies varies widely between operators. A study of 314,872 colonoscopies performed by 136 gastroenterologists found that the adenoma detection rate (ADR) ranged from 7 - 53% and was inversely associated with the risks of fatal interval cancer. The investigators have developed to tools that can generate automatic, computerized feedback in order to make a more thorough procedure and reduce patient discomfort, the Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS)
Objectives:
The investigators predict that live-feedback from CoPS and CoRS doing a colonoscopy can improve the ADR and subsequent prevent colorectal cancer. The aim of this project is to:
- In a cluster-randomized study compare if feedback from CoPS and CoRS can improve the adenoma detection rate and patient satisfaction for individual operators and the department as a whole.
- Make an immediate measure to assess the quality of individual colonoscopy performance.
Materials and methodology:
As a randomized controlled cluster trial following a stepped-wedge program, feedback doing a colonoscopy from these (CoPS and CoRS) will be tested compared to no feedback. Three test departments consisting of three University Hospital in the Capital region of Denmark will be included.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled cluster trial following a stepped-wedge randomization.
| Arm | Type | Receives |
|---|---|---|
| Feedback | Experimental | Device: Colonoscopy Progression Score (CoPS), Device: Colonoscopy Retraction Score (CoRS)Feedback system through CoPS and CoRS |
| Standard procedure | No intervention | –Performing the standard procedure in accordance with the departments usual conduct. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted for a screening colonoscopy through the Danish National Screening Program for Colorectal Cancer.
Key exclusion criteria (2 listed)
- In cases were the cecum is not reached.
- Unsatisfactory bowel preparation which results in admission for a new procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy Progression Score (CoPS)The Colonoscopy Progression Score consists of five different aspects: Travel length, Tip progression, chase efficiency, shaft movement without tip progression and looping. | Device | Feedback |
| Colonoscopy Retraction Score (CoRS)The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance. | Device | Feedback |
Primary outcome
Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole.
Time frame: Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.
The Adenoma Detection Rate of an operator is correlated to patient survival of colorectal cancer. A low Adenoma Detection Rate is correlated with a higher occurrence of interval cancer. Increasing the Adenoma Detection Rate will result in a more beneficial screening program with more cancers being caught in an earlier state and thereby increase patient survival.
Feedback from CoPS results in change in patient discomfort.
Time frame: Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.
Patient discomfort will be assessed by a post-procedure questionnaire. We will examine the correlation between the intervention and patient discomfort, and assess if more procedures can be completed due to less patient discomfort using the intervention.
1 secondary outcome
Make an immediate measure to assess the quality of individual colonoscopy performance.
Time frame: On data collection completion, estimated December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 42686507Cold KM, Vamadevan A, Heen A, Vilamann AS, Rasmussen M, Svendsen MBS, Konge L. Effect of a computer-aided quality feedback system on colonoscopists' adenoma detection rate in Denmark: a multicentre, stepped-wedge, cluster-randomised, controlled trial. Lancet Digit Health. 2026 Sep 2:101046. doi: 10.1016/j.landig.2026.101046. Online ahead of print.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
Kristoffer Mazanti Cold, MD principal investigator
PhD-alumni
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS) in people with Colorectal Cancer and Healthy, run by Copenhagen Academy for Medical Education and Simulation.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristoffer Mazanti Cold, MD (+4541442103, kristoffer.mazanti.cold@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole. (time frame: Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862793, which also lists 1 linked publication.
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 28 Apr 2021.