UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025485 |
|---|---|
| Receipt number | R000029197 |
| Scientific Title | A study on correlation between colonoscopy learning curve and adenoma detection rate of trainee gastroenterologist |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2019/01/05 10:05:07 |
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Basic information
Public title
A study on correlation between colonoscopy learning curve and adenoma detection rate of trainee gastroenterologist
Acronym
The correlation between colonoscopy learning curve and adenoma detection rate
Scientific Title
A study on correlation between colonoscopy learning curve and adenoma detection rate of trainee gastroenterologist
Scientific Title:Acronym
The correlation between colonoscopy learning curve and adenoma detection rate
Region
| Japan |
Condition
Condition
colon polyp
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate correlation between colonoscopy learning curve and adenoma detection rate
Basic objectives2
Others
Basic objectives -Others
to investigate correlation between colonoscopy learning curve and adenoma detection rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
correlation between the learning level of colonoscopy and adenoma detection rate
Key secondary outcomes
adenoma detection rate
number of colonoscopy
cecum incubation time
cecum incubation rate
withdrawal time
to explore risk factors of decreasing adenoma detection rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Trainee endoscopist
Male and Fele
Subjects who write informed consent
Key exclusion criteria
be not agreed
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Arimoto |
Organization
Yokohama City University, School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2640
junarimoto_junjun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Arimoto |
Organization
Yokohama City University, School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2640
Homepage URL
junarimoto_junjun@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiratsuka City Hospital, Chigasaki Citizen Hospital, Yokohama Rosai Hospital, Keiyu Hospital, Yokohama Sakaekyosai Hospital, Machida City Hospital, Yokohama City Hospital, Oomori red cross Hospital, Yokohama medical center
Name of secondary funder(s)
nothing
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
B160901005
Org. issuing International ID_1
Yokohama City Univerity Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院(神奈川県)、平塚市民病院(神奈川県)、茅ヶ崎市立病院(神奈川県)、横浜労災病院(神奈川県)、けいゆう病院(神奈川県)、横浜栄共済病院(神奈川県)、町田市民病院(東京都)、横浜市民病院(神奈川県)、大森赤十字病院(東京都)、横浜医療センター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 15 | Day |
Other
Other related information
We will investigate the correlation between colonoscopy learning curve and adenoma detection rate with 30 trainee gastroenterologists.
In addition, we also extract the risk factor of decreasing ADR.
Management information
Registered date
| 2016 | Year | 12 | Month | 31 | Day |
Last modified on
| 2019 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029197
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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