UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of prophylactic enoxaparin sodium in the prevention of venous thromboembolism after gynecological laparoscopic surgery
Title of the study (Brief title)	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

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

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	Hideaki Masuzaki
Organization	Nagasaki University
Division name	Department of Obstetrics and Gynecology
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	095-819-7363
Email	m-kita@nagasaki-u.ac.jp

Public contact
Name of contact person	Michio Kitjaima
Organization	Nagasaki University
Division name	Department of Obstetrics and Gynecology
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009751