UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034447 |
|---|---|
| Receipt number | 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 | 2020/06/23 18:44:30 |
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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 beginnerrs and pre-test in endoscopists except for experts and 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 | 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
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
| 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
260
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2018 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038391
