UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on correlation between colonoscopy learning curve and adenoma detection rate of trainee gastroenterologist
Title of the study (Brief title)	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	Jun Arimoto
Organization	Yokohama City University, School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2640
Email	junarimoto_junjun@yahoo.co.jp

Public contact
Name of contact person	Jun Arimoto
Organization	Yokohama City University, School of Medicine
Division name	Department of Gastroenterology and Hepatology
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

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029197