Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
3000 participants
INTERVENTIONAL
2021-06-30
2023-12-31
Brief Summary
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Detailed Description
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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:
1. 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.
2. 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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Feedback
Feedback system through CoPS and CoRS
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.
Colonoscopy Retraction Score (CoRS)
The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.
Standard procedure
Performing the standard procedure in accordance with the departments usual conduct.
No interventions assigned to this group
Interventions
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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.
Colonoscopy Retraction Score (CoRS)
The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unsatisfactory bowel preparation which results in admission for a new procedure
18 Years
ALL
Yes
Sponsors
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Danish Cancer Society
OTHER
Ambu A/S
INDUSTRY
Region Capital Denmark
OTHER
Herlev Hospital
OTHER
Bispebjerg Hospital
OTHER
Hillerod Hospital, Denmark
OTHER
Copenhagen Academy for Medical Education and Simulation
OTHER
Responsible Party
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Kristoffer Mazanti Cold
Principal Investigator
Principal Investigators
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Kristoffer Mazanti Cold, MD
Role: PRINCIPAL_INVESTIGATOR
PhD-alumni
Central Contacts
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Other Identifiers
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P-2021-256
Identifier Type: -
Identifier Source: org_study_id
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