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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008435

Enrollment

300

Registered

2012-08-01

Start date

2012-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancers

Interventions

Once daily fondaparinux (2.5mg or 1.5mg) for 4 to 8 days after 24 hours of surgery Intermittent pneumatic compression according to the institutional guidelines

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients under going laparoscopic colorectal surgery and have additional risk factor for VTE. 2) Patients with confirmed colorectal cancer by endoscopic examination. 3) Patients of age=>70 4) Sufficient function of important organs (obrained within 42 day of registration) 1.WBC: >=3,000 /mm3 2. Platelet : >= 100,000 /mm3 3.Total bil: <= 2.0 mg/dl 4.AST, ALT : <=100 IU/L 6.Serum creatinin : <= 1.5 mg/dL 5) Pre-operative D-dimer < 1ug/ml or less than twice of institution limit 6)With written informed consent

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Incidence of venous thromboembolism (VTE)	—

Secondary

Measure	Time frame
Incidence of major bleeding	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026