Increasing Serrated Polyp Detection With a Brief Awareness Training

NCT03902899 | Completed

• 1 other identifier: DW18001
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Serrated Polyp; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to five years (between 2014 and 2018)

Secondary Outcomes (1)

• Adenoma detection rate (ADR)

  Up to five years (between 2014 and 2018)

Study Arms (2)

Intervention-arm

EXPERIMENTAL

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.

Other: Educational intervention (oral presentation)

Control arm

NO INTERVENTION

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.

Interventions

Educational intervention (oral presentation) OTHER

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

Intervention-arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• National Institute for Public Health and the Environment (RIVM): collaborator

Related Publications (1)

• 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.

  PMID: 32139550 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The investigator personally delivers the training and can thus not be blinded for the endoscopists allocated to the intervention-arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: April 4, 2019
• Study Start: January 1, 2014
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share