UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective examination of the after-bleeding by the antithrombotic drug in endoscopic mucosal resection or polypectomy for colon polyps.
Title of the study (Brief title)	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	mitsusige sugimoto
Organization	Shiga University of Medical Science Hospital.
Division name	Division of Digestive Endoscopy
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	077-548-2217
Email	mura0531@belle.shiga-med.ac.jp

Public contact
Name of contact person	masaki murata
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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