Phase III study of efficacy of fondaparinux on the prevention of post-operative venous thromboembolism in patients undergoing with laparoscopic colorectal cancer surgery.

Phase 3

• Conditions: Colorectal cancers

• Registration Number: JPRN-UMIN000008435
• Lead Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2013-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with active bleeding 2)Thrombocytopenia plt<10x104/uL 3) Patients with a risk of bleeding: GI ulcers, diverticulitis, colitis, acute bacterial endocarditis, uncontrolled severe hypertension, Uncontrolled diabetes mellitus, DIC 4) Severe liver dysfunction (Child C) 5) Known hypersensitivity of unfractionated heparin, low molecular heparin, and heparinoids) 6) History of cranial bleeding 7) Patients underwent central cranial operation, spine operation or ophthalmic surgery within 3 months before registration 8) Severe renal dysfunction (Cr clearance < 20ml/min) 9) Known hypersensitivity of contrast media 10) Other patients who are unfit for the study as determined by the attending physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of venous thromboembolism (VTE)

Secondary Outcome Measures

Name	Time	Method
Incidence of major bleeding