UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041285 |
|---|---|
| Receipt number | R000046597 |
| Scientific Title | The prospective study of the effect of the educational program for predicting the morphology of colorectal polyps |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2025/04/07 10:09:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The prospective study of the effect of the educational program for predicting the morphology of colorectal polyps
Acronym
The study of the educational program for the morphology of polyps
Scientific Title
The prospective study of the effect of the educational program for predicting the morphology of colorectal polyps
Scientific Title:Acronym
The study of the educational program for the morphology of polyps
Region
| Japan |
Condition
Condition
colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the education program for predicting the morphology of colorectal polyps in endoscopists
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of the education program for predicting the morphology of colorectal polyps
Key secondary outcomes
1.The effect of the education program for predicting the morphology of colorectal polyps in beginners, intermediates, and experts
2.The improvement of intraobserver agreement
3.The appearance of the polyps and endoscopoists with poor accuracy and effect of the education program
4.The accuracy and change of accuracy in each morphologies
5.The difference of diagnostic accuracy and intraobserver agreement between pre-test and post-test
6.Whether the educational effect is maintained
7.The accuracy and intraobserver agreement in predicting the morphology of colorectal polyps based on Japanese classification of colorectal carcinoma
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The education using a video for the diagnosis of the polyp morphology
Interventions/Control_2
No educational videos
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Endoscopists who provided consent to participate in the study.
Key exclusion criteria
Endoscopists who are late for the deadline of tests
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Seno |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
seno@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Utsumi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
Homepage URL
tk_utsumi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gastrointestinal Center, Sano Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC11791016/
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC11791016/
Number of participants that the trial has enrolled
296
Results
The mean pre-test accuracies in the pre-education and post-education groups were 60.6% and 60.7%, respectively. The difference in diagnostic accuracy between the pre-test and diagnostic test was significantly higher in the post-education than the pre-education group (12.0 points, 95%CI 9.9-14.1 and 2.3 points, 95% CI 0.9-3.6; p < 0.001).
This multicenter randomized controlled trial demonstrated the usefulness of a short educational video for accurate polyp morphology assessment.
Results date posted
| 2025 | Year | 04 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gastrointestinal endoscopists from Japan were recruited between October and December 2021. The inclusion criteria were: all endoscopists who provided consent to participate in our study. All participants answered questions on their background and endoscopic experience, including sex (male/female), endoscopic experience (months), total number of colonoscopies conducted, number of colonoscopies conducted in the last year, and the presence of accreditation by the Japan Gastroenterological Endoscopy Society at enrollment. The exclusion criteria were as follows: (1) withdrawal of consent, (2) delay in answering the test questions, and (3) having an unresolved network problem when answering the test questions and watching the educational video.
Participant flow
First, the participants were asked to take the pre-test online. Participants distributed according to their pre-test scores as an adjusting factor were randomly assigned to the pre- or post-education groups. Participants who had high score in the pre-test were excluded from the primary outcome analysis. The educational video was accessible online to all participants for one month, from February 17 to March 16, 2022. Participants reported the number of times they viewed the educational video in the diagnostic test. Participants in the pre-education group answered the diagnostic test within 2 weeks before the distribution of the educational video, and those in the post-education group answered the diagnostic test within 2 weeks after the period during which the educational videos were available. Finally, 3 months after watching the short educational video, the participants undertook the post-test to assess the sustainability of the video's educational effects.
Adverse events
None
Outcome measures
Primary outcome measure
The primary outcome measure was the difference in diagnostic accuracy between the pre-test and diagnostic tests in the pre- and post- education groups.
Secondary outcome measures
Secondary outcome measures were: 1) the changes of accuracy in each morphology and subtype identification between the pre-test and diagnostic test in the post-education group; 2) changes in accuracy rate between the diagnostic test and post-test in the post-education group for investigating whether the educational effect is maintained; 3) multivariate analysis of factors that contribute to the educational effectiveness of the short educational video in the post-education group with high-score participants.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046597
