UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029544 |
|---|---|
| Receipt number | 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 16:13:18 |
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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
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
mura0531@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science.Division of Gastroenterology.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033756
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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