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Recruitment status Completed
Unique ID issued by UMIN UMIN000008273
Receipt No. R000009751
Scientific Title Evaluation of prophylactic enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Date of disclosure of the study information 2012/07/31
Last modified on 2018/01/09

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Basic information
Public title Evaluation of prophylactic enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Acronym Enoxaparin sodium in gynecological laparoscopy
Scientific Title Evaluation of prophylactic enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Scientific Title:Acronym Enoxaparin sodium in gynecological laparoscopy
Region
Japan

Condition
Condition benign gynecological disease
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of effectiveness and safety of enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes development of VTE after surgery
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 administration of enoxaparin sodium
Interventions/Control_2 control (without enoxaparin sodium)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria women undergoing laparoscopic surgery for benign gynecological disease
Key exclusion criteria allergy to heparin or related products
bleeding symptom
acute bacterial endocarditis
history of heparin related thrombocytopenia
renal failure
bodyweight less than 40kg
any clinical signs of VTE at screening or within 1 year before surgery
systemic chemo-therapy within 3 weeks before surgery
radiation therapy within 15 days before surgery
spinal or epidural anesthesia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Masuzaki
Organization Nagasaki University
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7363
Email m-kita@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Kitjaima
Organization Nagasaki University
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7363
Homepage URL
Email m-kita@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Nagasaki University
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 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 07 Month 31 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
2012 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 26 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009751


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