UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007005 |
|---|---|
| Receipt number | R000008265 |
| Scientific Title | The efficacy and safety of anticoagulant therapy Arixtra Injection for the prevention of the vein thromboembolism in laparoscopic colorectal surgery |
| Date of disclosure of the study information | 2012/01/10 |
| Last modified on | 2012/01/03 20:52:26 |
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Basic information
Public title
The efficacy and safety of anticoagulant therapy Arixtra Injection for the prevention of the vein thromboembolism in laparoscopic colorectal surgery
Acronym
The efficacy and safety of anticoagulant therapy Arixtra Injection for the prevention of the vein thromboembolism in laparoscopic colorectal surgery
Scientific Title
The efficacy and safety of anticoagulant therapy Arixtra Injection for the prevention of the vein thromboembolism in laparoscopic colorectal surgery
Scientific Title:Acronym
The efficacy and safety of anticoagulant therapy Arixtra Injection for the prevention of the vein thromboembolism in laparoscopic colorectal surgery
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the efficacy and safety of anticoagulant therapy Arixtra Injection for the prevention of the vein thromboembolism in laparoscopic colorectal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of the incidence of venous thromboembolism. The safety of the incidence of Major bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fondaparinux
Interventions/Control_2
none
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
Patients underwent laparocopic surgery for colorectal cancer
Key exclusion criteria
patients who are thout to be inapropreate for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka Medical College
Division name
Department of General and Gastroenterological Surgery
Zip code
Address
2-7 Daigakumachi, Takatsuki-City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka Medical College
Division name
Department of General and Gastroenterological Surgery
Zip code
Address
2-7 Daigakumachi, Takatsuki-City
TEL
Homepage URL
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 10 | 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
| 2011 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 03 | Day |
Last modified on
| 2012 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008265
