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

Phase 3

• Conditions: Gastric or colorectal cancer patients planned to receive laparoscopic surgery

• Registration Number: JPRN-UMIN000009901
• Lead Sponsor: Division of Gastrointestinal Surgery, Department of Surgery, Tohoku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-01
• Study Completion: 2017-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified