UMIN-CTR Clinical Trial

Basic information
Public title	Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Acronym	Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Scientific Title	Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Scientific Title:Acronym	Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Region	Japan

Condition
Condition	Colonic polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establishment of the methodology of training endoscopists including individual feedback system for improving adenoma detection rate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adenoma detection rate Polyp detection rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Feedback group
Interventions/Control_2	Control group
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who underwent screening colonoscopy in the institute from August, 2018 to March, 2019.
Key exclusion criteria	Patients who underwent surgical resection of the colon or rectum, patients who suffered from inflammatory bowel disease or familial adenomatous polyposis excluded.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Fumiaki Middle name Last name Ishibashi
Organization	Shinjuku Tsurukame Clinic
Division name	Digestive Disease Center
Zip code	151-0053
Address	2-11-15-3F Yoyogi, Shibuya-ku, Tokyo, Japan
TEL	03-3299-0077
Email	ishibashi@tsurukamekai.jp

Public contact
Name of contact person	1st name Fumiaki Middle name Last name Ishibashi
Organization	Shinjuku Tsurukame Clinic
Division name	Digestive Disease Center
Zip code	151-0053
Address	2-11-15-3F Yoyogi, Shibuya-ku, Tokyo, Japan
TEL	03-3299-0077
Homepage URL
Email	ishibashi@tsurukamekai.jp

Sponsor
Institute	Shinjuku Tsurukame Clinic
Institute
Department

Funding Source
Organization	None
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	Shinjuku Tsurukame Clinic
Address	2-11-15-3F Yoyogi, Shibuya-ku, Tokyo, Japan
Tel	03-3299-0077
Email	ishibashi@tsurukamekai.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	新宿つるかめクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 10 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	1728
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 07 Month 31 Day
Date of IRB	2018 Year 07 Month 18 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 01 Month 05 Day
Date analysis concluded	2020 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 09 Month 25 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043419