Colorectal Cancer, Healthy
Conditions
Keywords
Colonoscopy, Adenoma Detection Rate, Computerized Feedback
Brief 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.
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: 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.
Interventions
DEVICEColonoscopy 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.
DEVICEColonoscopy Retraction Score (CoRS)
The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.
Sponsors
Danish Cancer Society
Ambu A/S
Region Capital Denmark
Herlev Hospital
Bispebjerg Hospital
Hillerod Hospital, Denmark
Copenhagen Academy for Medical Education and Simulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A randomized controlled cluster trial following a stepped-wedge randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Admitted for a screening colonoscopy through the Danish National Screening Program for Colorectal Cancer.
Exclusion criteria
Incomplete procedure due to: * In cases were the cecum is not reached. * Unsatisfactory bowel preparation which results in admission for a new procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Make an immediate measure to assess the quality of individual colonoscopy performance. | On data collection completion, estimated December 2023 | 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. |
Contacts
Primary ContactKristoffer Mazanti Cold, MD
Backup ContactLars Konge, MD, PhD
Outcome results
None listed