Increasing Serrated Polyp Detection With a Brief Awareness Training

• ClinicalTrials.gov Identifier: NCT03902899
• Recruitment Status: Completed
• First Posted: April 4, 2019
• Last Update Posted: April 4, 2019
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: National Institute for Public Health and the Environment (RIVM)
• Information provided by (Responsible Party): Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease	Intervention/treatment	Phase
Serrated Polyp; Colorectal Neoplasms	Other: Educational intervention (oral presentation)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 138 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.
• Primary Purpose: Health Services Research
• Official Title: The Influence of a Short Training in the Detection Rate of Proximal Serrated Polyps in an Asymptomatic Patient Population
• Actual Study Start Date: January 1, 2014
• Actual Primary Completion Date: October 26, 2018
• Actual Study Completion Date: October 26, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Proximal serrated polyp detection rate (PSPDR) [ Time Frame: Up to five years (between 2014 and 2018) ]
   Rate/proportion of an endoscopist's colonoscopies with one or more serrated polyps proximal to or in splenic flexure.

Secondary Outcome Measures :

1. Adenoma detection rate (ADR) [ Time Frame: Up to five years (between 2014 and 2018) ]
   Rate/proportion of an endoscopist's colonoscopies with one or more adenomas

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prof. Evelien Dekker, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT03902899
• Other Study ID Numbers: DW18001
• First Posted: April 4, 2019
• Last Update Posted: April 4, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colorectal Neoplasms; Polyps; Pathological Conditions, Anatomical; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases