Computerized Feedback in Colonoscopy
Primary Purpose
Colorectal Cancer, Healthy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Colonoscopy Progression Score (CoPS)
Colonoscopy Retraction Score (CoRS)
Sponsored by

About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colonoscopy, Adenoma Detection Rate, Computerized Feedback
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Feedback
Standard procedure
Arm Description
Feedback system through CoPS and CoRS
Performing the standard procedure in accordance with the departments usual conduct.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04862793
First Posted
April 21, 2021
Last Updated
April 23, 2021
Sponsor
Copenhagen Academy for Medical Education and Simulation
Collaborators
Danish Cancer Society, Ambu A/S, Region Capital Denmark, Herlev Hospital, Bispebjerg Hospital, Hillerod Hospital, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04862793
Brief Title
Computerized Feedback in Colonoscopy
Official Title
Impact of Computerized Feedback During Colonoscopy on Adenoma Detection Rate of Colorectal Cancer and Patient Related Satisfaction: A Cluster-randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen Academy for Medical Education and Simulation
Collaborators
Danish Cancer Society, Ambu A/S, Region Capital Denmark, Herlev Hospital, Bispebjerg Hospital, Hillerod Hospital, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Healthy
Keywords
Colonoscopy, Adenoma Detection Rate, Computerized Feedback
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled cluster trial following a stepped-wedge randomization.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feedback
Arm Type
Experimental
Arm Description
Feedback system through CoPS and CoRS
Arm Title
Standard procedure
Arm Type
No Intervention
Arm Description
Performing the standard procedure in accordance with the departments usual conduct.
Intervention Type
Device
Intervention Name(s)
Colonoscopy Progression Score (CoPS)
Intervention Description
The Colonoscopy Progression Score consists of five different aspects: Travel length, Tip progression, chase efficiency, shaft movement without tip progression and looping.
Intervention Type
Device
Intervention Name(s)
Colonoscopy Retraction Score (CoRS)
Intervention Description
The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.
Primary Outcome Measure Information:
Title
Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole.
Description
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.
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.
Title
Feedback from CoPS results in change in patient discomfort.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Make an immediate measure to assess the quality of individual colonoscopy performance.
Description
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.
Time Frame
On data collection completion, estimated December 2023
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristoffer Mazanti Cold, MD
Phone
+4541442103
Email
kristoffer.mazanti.cold@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Konge, MD, PhD
Phone
+4530230210
Email
lars.konge@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristoffer Mazanti Cold, MD
Organizational Affiliation
PhD-alumni
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
At end of data collection (December 2023) and for the following 5 years.
IPD Sharing Access Criteria
On request to the primary investigator with a useful scientific purpose.
Learn more about this trial
Computerized Feedback in Colonoscopy
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