Gastric or colorectal cancer patients planned to receive laparoscopic surgery
Conditions
Interventions
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 ho
Sponsors
Division of Gastrointestinal Surgery, Department of Surgery, Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of incidence of all the venous thromboembolism including deep vein thrombosis and pulmonary thromboembolism | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoki Tanaka
Tohoku University Hospital Division of Gastrointestinal Surgery, Department of Surgery
Outcome results
None listed