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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041285
Receipt No. 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 2020/08/03

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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
Email 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
Email tk_utsumi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 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
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046597

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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