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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029544
Receipt No. R000033756
Scientific Title Retrospective examination of the after-bleeding by the antithrombotic drug in endoscopic mucosal resection or polypectomy for colon polyps.
Date of disclosure of the study information 2017/10/13
Last modified on 2017/10/13

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Basic information
Public title Retrospective examination of the after-bleeding by the antithrombotic drug in endoscopic mucosal resection or polypectomy for colon polyps.
Acronym Retrospective examination of the after-bleeding of the endoscopic treatment by the antithrombotic drug.
Scientific Title Retrospective examination of the after-bleeding by the antithrombotic drug in endoscopic mucosal resection or polypectomy for colon polyps.
Scientific Title:Acronym Retrospective examination of the after-bleeding of the endoscopic treatment by the antithrombotic drug.
Region
Japan

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

Objectives
Narrative objectives1 We examine an after-bleeding rate and thromboembolism incidence according to the type of each antithrombotic drug in EMR or polypectomy retrospectively.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination of the bleeding risk of the endoscopic treatment of various antithrombotic drugs.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who performed EMR and polypectomy for polyps of colon with Shiga University of Medical Science digestive organ internal medicine by March 31, 2016 after January 1, 2014.
Key exclusion criteria no
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name mitsusige sugimoto
Organization Shiga University of Medical Science Hospital.
Division name Division of Digestive Endoscopy
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2217
Email mura0531@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name masaki murata
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2217
Homepage URL
Email mura0531@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science.Division of Gastroenterology.
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 29-172
Org. issuing International ID_1 Shiga University of Medical Science Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 13 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We observe The patients who performed EMR and polypectomy in the endoscope for polyp of colon with Shiga University of Medical Science by March 31, 2016 after January 1, 2014.

Management information
Registered date
2017 Year 10 Month 13 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033756

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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