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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025485
Receipt No. 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

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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
Email 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
Email junarimoto_junjun@yahoo.co.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029197

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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