UMIN-CTR Clinical Trial

Basic information
Public title	Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Acronym	Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Scientific Title	Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Scientific Title:Acronym	Prevention of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Region	Japan

Condition
Condition	Gastric and colon cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the preventing efficacy of postoperative VTE using Enoxaparin in laparoscopic gastrectomy and colectomy for malignancies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of VTE.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Administration of Enoxaparin(2000IU twice a day, POD1-7) and mechanical thromboprophylaxis(POD1)
Interventions/Control_2	mechanical thromboprophylaxis(POD1)
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Postoperative function of the major organs(bone marrow, liver, kidneys, etc.) are held sufficiently; patients that meet the following criteria (hemoglobin : 9.5g/dl or more, ALT and AST: 2.5 times less than the normal value of the facility, total bilirubin: 3.0mg/dl or less, SpO2: 90% or more).
Key exclusion criteria	1)Patients with heparin-induced thrombocytopenia or patients with a history of hypersensitivity of to heparin or related substances(HIT). 2)Patients with acute bacterial endocarditis 3)Patients with severe to moderate renal dysfunction(creatinine clearance below 50mL/min). 4)Patients with severe liver failure. 5)Low-weight patients (weight less than 40kg) 6)Women who may possibly be pregnant or are pregnant. 7)Patients receiving antiplatelet drugs (such as clopidogrel or aspirin) or anticoagulant drugs (warfarin etc.) affecting hemostasis preoperatively. 8)Patients with venous thromboembolic disease was observed within one year prior to surgery of this study or the patient with clinical signs or merger of deep vein thrombosis. 9)Ppatients with contraindications of iodinated contrast agent. 10)Patients who have indwelling central venous catheter. 11)Patients treated with progesterone and estrogen formulation within 4 weeks before administration. 12)Patients receiving radiation therapy or systemic cancer chemotherapy within two weeks before the administration. 13)Patients is determined inappropriate as a test target by principal investigator.
Target sample size	450

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akinobu Taketomi
Organization	Hokkaido Univ. Graduated School of Medicine
Division name	Gastroenterological Surgery 1
Zip code
Address	N15, W-7, Kita-ku Sapporo, Hokkaido
TEL	011-706-5927
Email	taketomi@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hirofumi Kamachi
Organization	Hokkaido Univ. Graduated School of Medicine
Division name	Gastroenterological Surgery 1
Zip code
Address	N15, W-7, Kita-ku Sapporo, Hokkaido
TEL	011-706-5927
Homepage URL
Email	hkamachi@db3.so-net.ne.jp

Sponsor
Institute	Gastroenterological Surgery 1 Hokkaido Univ. Graduated School of Medicine
Institute
Department

Funding Source
Organization	Gastroenterological Surgery 1 Hokkaido Univ. Graduated School of Medicine
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
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	2013 Year 10 Month 01 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	2013 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 09 Day
Last follow-up date	2017 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 06 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013638

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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