UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023637 |
|---|---|
| Receipt number | R000027006 |
| Scientific Title | Analysis of risk factors of bleeding after endoscopic surgery and evaluation of perioperative safety for users of anticoagulants |
| Date of disclosure of the study information | 2016/08/16 |
| Last modified on | 2020/06/18 20:05:44 |
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Basic information
Public title
Analysis of risk factors of bleeding after endoscopic surgery and evaluation of perioperative safety for users of anticoagulants
Acronym
Management of the anticoagulant in endoscopic surgery
Scientific Title
Analysis of risk factors of bleeding after endoscopic surgery and evaluation of perioperative safety for users of anticoagulants
Scientific Title:Acronym
Management of the anticoagulant in endoscopic surgery
Region
| Japan |
Condition
Condition
gastric cancer, esophageal cancer, colon polyp, colon cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze risk factors of bleeding after endoscopic surgery and to evaluate validity and safety of perioperative discontinuation of anticoagulants
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bleeding rates and risk factors for bleeding after endoscopic surgery
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Users of anticoagulants who receive endoscopic surgery
Key exclusion criteria
Patients who are not adequate to study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Divison of Endoscopy
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL
0117161161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Divison of Endoscopy
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL
0117161161
Homepage URL
onosho@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
To evaluate bleeding and embolic events after endoscopic surgery for one month.
Management information
Registered date
| 2016 | Year | 08 | Month | 16 | Day |
Last modified on
| 2020 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027006
