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Increasing Serrated Polyp Detection With a Brief Awareness Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902899
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
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)

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

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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

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.



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



Information from the National Library of Medicine

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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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