search
Back to results

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
Copenhagen Academy for Medical Education and Simulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colonoscopy, Adenoma Detection Rate, Computerized Feedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
    search

    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

    We'll reach out to this number within 24 hrs