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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034447
Receipt No. R000038391
Scientific Title The prospective study of the effect of the educational program for predicting the size of colorectal polyps
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/08

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Basic information
Public title The prospective study of the effect of the educational program for predicting the size of colorectal polyps
Acronym The study of the educational program for the size of polyps
Scientific Title The prospective study of the effect of the educational program for predicting the size of colorectal polyps
Scientific Title:Acronym The study of the educational program for the size 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 size of colorectal polyps in the beginners of the lower gastrointestinal endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of diagnostic accuracy between pre-test and post-test in beginners
Key secondary outcomes 1.The difference of diagnostic accuracy between pre-test and post-test in experts
2.The difference of diagnostic accuracy between pre-test and post-test in endoscopists except for experts and beginners
3.The difference of diagnostic accuracy between pre-test and post-test in endoscopists
4.The difference of diagnostic accuracy between post-test in beginnerrs and pre-test in experts
5.The difference of diagnostic accuracy between post-test in beginnerrs and pre-test in endoscopists except for experts and beginners
6.The difference of diagnostic accuracy between post-test in endoscopists except for experts and beginners and pre-test in experts
7.The appearance of the case with poor accuracy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 The education for the diagnosis of the polyp size with videos in beginners
Interventions/Control_2 The education for the diagnosis of the polyp size with videos in endoscopists except for beginners and experts
Interventions/Control_3 The education for the diagnosis of the polyp size with videos in experts
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 Nothing
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Seno
Organization Kyoto University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Takahiro Utsumi
Organization Kyoto University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 12 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
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 11 Day
Last modified on
2018 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038391

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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