Increasing Serrated Polyp Detection With a Brief Awareness Training

NCT ID: NCT03902899

Last Updated: 2019-04-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-10-26

Brief Summary

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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.

Detailed Description

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Conditions

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Serrated Polyp Colorectal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

The investigator personally delivers the training and can thus not be blinded for the endoscopists allocated to the intervention-arm.

Study Groups

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Intervention-arm

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.

Group Type EXPERIMENTAL

Educational intervention (oral presentation)

Intervention Type OTHER

A brief oral presentation (30-45 minutes) which focused on making endoscopists aware of the significance and characteristics of serrated polyps.

Control arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational intervention (oral presentation)

A brief oral presentation (30-45 minutes) which focused on making endoscopists aware of the significance and characteristics of serrated polyps.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Public Health and the Environment (RIVM)

OTHER_GOV

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Prof. Evelien Dekker, MD, PhD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 32139550 (View on PubMed)

Other Identifiers

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DW18001

Identifier Type: -

Identifier Source: org_study_id

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