UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Multicenter, Open-label, Prospective Randomized Controlled Trial to evaluate the Effect of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Surgery
Title of the study (Brief title)	Effect of LMWH on Prevention of VTE after Laparoscopic Surgery
Region	Japan

Condition
Condition	Gastric or colorectal cancer patients planned to receive laparoscopic surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the additive effect of combined therapy with physical prophylaxis and Low-Molecular-Weight Heparin against thromboembolism compared to physical prophylaxis alone, after laparoscopic surgery for gastric or colorectal cancer by multicenter, open-label, prospective randomized controlled trial
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	The rate of incidence of all the venous thromboembolism including deep vein thrombosis and pulmonary thromboembolism
Key secondary outcomes	The rate of incidence of pulmonary thromboembolism The rate of incidence of deep vein thrombosis The rate of incidence of major and minor bleeding The rate of incidence of all the adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	For patients allocated to the trial group, a subcutaneous injection of enoxaparin 2000 IU twice daily is administered, in addition to conventional physical prophylaxis. Enoxaparin was started 24-36 hours after surgery and continued until 7th post operative day.
Interventions/Control_2	For patients allocated to the control group, conventional physical prophylaxis such as elastic stocking and / or intermittent pneumatic compression device is provided for a few days
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	1) A patients with histopathologically diagnosed gastric or colorectal cancer 2) Planned to receive laparoscopic surgery. 3) Planned to receive curative operation. 4) Over 40 years old at registration. 5) ECOG Performance Status Scale: 0-2. 6) Able to provide written informed consent.
Key exclusion criteria	1) History of allergic reaction to heparin and / or heparinoid, or heparin-induced thrombocytopenia 2) Coexistence / past history of acute bacterial endocarditis 3) Moderate to severe renal dysfunction (50mL/min >= CCr) 4) Severe liver dysfunction 5) Body weight under 40 Kg 6) During pregnancy and lactation 7) Administration of anticoagulant and / or antiplatelet agent such as warfarin, aspirin and clopidogrel sulfate before operation. 8) Morbid obesity (30<=BMI) 9) Coexistence / clinical sign of venous thromboembolism, past history of venous thromboembolism within one year till the scheduled date of surgery 10) With indwelling central venous catheter 11) Administration of estrogen / progesteronal agents within four weeks prior to the operation. 12) Neo-adjuvant chemotherapy /radiotherapy within four weeks prior to the operation 13) Abnormal high value of D-dimer (=> 10 microg/mL) within four weeks prior to the operation 14) Any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study
Target sample size	400

Research contact person
Name of lead principal investigator	Naitoh Takeshi
Organization	Tohoku University Hospital
Division name	Division of Gastrointestinal Surgery, Department of Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7205
Email	naitot@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Naoki Tanaka
Organization	Tohoku University Hospital
Division name	Division of Gastrointestinal Surgery, Department of Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7205
Homepage URL
Email	n-tanaka@surg1.med.tohoku.ac.jp

Sponsor
Institute	Division of Gastrointestinal Surgery, Department of Surgery, Tohoku University Hospital
Institute
Department

Funding Source
Organization	NEXTSURG
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	東北大学病院（宮城県）、東北労災病院（宮城県）、仙台厚生病院（宮城県）、仙台市医療センター　仙台オープン病院（宮城県）、みやぎ県南中核病院（宮城県）、宮城県立がんセンター（宮城県）、帯広第一病院（北海道）、東北厚生年金病院（宮城県）、東北中央病院（山形県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 01 Month 30 Day
Anticipated trial start date	2013 Year 05 Month 22 Day
Last follow-up date	2017 Year 01 Month 31 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 07 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 30 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010691