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Increasing Serrated Polyp Detection With a Brief Awareness Training

Primary Purpose

Serrated Polyp, Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational intervention (oral presentation)
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Serrated Polyp

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

- Endoscopists accredited to perform colonoscopies within the Dutch Nationwide colorectal cancer screening program

Exclusion criteria:

- Absent during both training sessions while employed in one of the trained hospitals

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention-arm

    Control arm

    Arm Description

    All endoscopists employed by 9 semi-randomly chosen hospitals in the Netherlands will be exposed to an educational intervention (oral presentation): an oral awareness training which will be delivered twice, first in 2014 and then in 2016/2017. In total 38 endoscopists are included from these 9 hospitals.

    A random set of 100 endoscopists will be selected ass a reference group. These 100 endoscopists were unaware of the present study, and were thus blinded for their allocation.

    Outcomes

    Primary Outcome Measures

    Proximal serrated polyp detection rate (PSPDR)
    Rate/proportion of an endoscopist's colonoscopies with one or more serrated polyps proximal to or in splenic flexure.

    Secondary Outcome Measures

    Adenoma detection rate (ADR)
    Rate/proportion of an endoscopist's colonoscopies with one or more adenomas

    Full Information

    First Posted
    January 4, 2019
    Last Updated
    April 2, 2019
    Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Collaborators
    National Institute for Public Health and the Environment (RIVM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03902899
    Brief Title
    Increasing Serrated Polyp Detection With a Brief Awareness Training
    Official Title
    The Influence of a Short Training in the Detection Rate of Proximal Serrated Polyps in an Asymptomatic Patient Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    October 26, 2018 (Actual)
    Study Completion Date
    October 26, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Collaborators
    National Institute for Public Health and the Environment (RIVM)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this non-randomized controlled trial, a semi-random group of Dutch endoscopist receive an oral training about the significance of serrated polyps. The primary aim of this training is to improve the endoscopist's awareness of the significance of serrated polyps, ultimately leading to increased detection. In addition, a random group of endoscopists that will not receive this training will be used as a reference group. Data will be collected as part of routine care within the Nationwide Dutch Bowel cancer screening program. The serrated polyp detectionrate of each endoscopist will be extracted from anonymized data that will be prospectively collected as part of routine care within the Dutch Nationwide bowel cancer screening program. Data will be anonymized and provided by Rijksinstituut voor Volksgezondheid en Milieu (RIVM) and ScreenIT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Serrated Polyp, Colorectal Neoplasms

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a non-randomized controlled trial with two arms. The intervention-arm consists of all endoscopists employed by 9 semi-randomly chosen Dutch hospitals hospitals who receive an educational training. The control-arm consists of a specific number of randomly chosen endoscopists.
    Masking
    None (Open Label)
    Masking Description
    The investigator personally delivers the training and can thus not be blinded for the endoscopists allocated to the intervention-arm.
    Allocation
    Non-Randomized
    Enrollment
    138 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention-arm
    Arm Type
    Experimental
    Arm Description
    All endoscopists employed by 9 semi-randomly chosen hospitals in the Netherlands will be exposed to an educational intervention (oral presentation): an oral awareness training which will be delivered twice, first in 2014 and then in 2016/2017. In total 38 endoscopists are included from these 9 hospitals.
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    A random set of 100 endoscopists will be selected ass a reference group. These 100 endoscopists were unaware of the present study, and were thus blinded for their allocation.
    Intervention Type
    Other
    Intervention Name(s)
    Educational intervention (oral presentation)
    Intervention Description
    A brief oral presentation (30-45 minutes) which focused on making endoscopists aware of the significance and characteristics of serrated polyps.
    Primary Outcome Measure Information:
    Title
    Proximal serrated polyp detection rate (PSPDR)
    Description
    Rate/proportion of an endoscopist's colonoscopies with one or more serrated polyps proximal to or in splenic flexure.
    Time Frame
    Up to five years (between 2014 and 2018)
    Secondary Outcome Measure Information:
    Title
    Adenoma detection rate (ADR)
    Description
    Rate/proportion of an endoscopist's colonoscopies with one or more adenomas
    Time Frame
    Up to five years (between 2014 and 2018)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: - Endoscopists accredited to perform colonoscopies within the Dutch Nationwide colorectal cancer screening program Exclusion criteria: - Absent during both training sessions while employed in one of the trained hospitals

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32139550
    Citation
    Bleijenberg AGC, van Leerdam ME, Bargeman M, Koornstra JJ, van Herwaarden YJ, Spaander MC, Sanduleanu S, Bastiaansen BAJ, Schoon EJ, van Lelyveld N, Dekker E, IJspeert JEG. Substantial and sustained improvement of serrated polyp detection after a simple educational intervention: results from a prospective controlled trial. Gut. 2020 Dec;69(12):2150-2158. doi: 10.1136/gutjnl-2019-319804. Epub 2020 Mar 5.
    Results Reference
    derived

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    Increasing Serrated Polyp Detection With a Brief Awareness Training

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