UMIN-CTR Clinical Trial

Basic information
Public title	A study on correlation between colonoscopy learning curve and adenoma detection rate of young 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 young 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 rise ADR
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	ADR: Adenoma Detection Rate
Key secondary outcomes	the doctor side risk factors of decreasing ADR the patient side risk factors of decreasing ADR cecum incubation time withdrawal time

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	over 20 years old, less than 90 years old all patients who are performed colonoscopy Male and Female Patients who write informed consent
Key exclusion criteria	Patients with inflammatory bowel diseases Patients post colon surgery In addition, when researcher judge that the patients are not appropriate as the research subject
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Jun Middle name Last name Arimoto
Organization	Yokohama City University, School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2640
Email	junarimoto_junjun@yahoo.co.jp

Public contact
1st name of contact person	1st name Jun Middle name Last name Arimoto
Organization	Yokohama City University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
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
Name of secondary funder(s)	nothing

IRB Contact (For public release)
Organization	Yokohama City University School of Medicine
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
Tel	045-787-2800
Email	onodera@yokohama-cu.ac.jp

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)

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 25 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 11 Month 25 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 learning curve and ADR with 30 young gastroenterologists (trainees). In addition, we also extract the risk factor of decreasing ADR.

Management information
Registered date	2016 Year 11 Month 21 Day
Last modified on	2019 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028663