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Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)

Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study) - Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018633
Enrollment
120
Registered
2015-08-15
Start date
2015-08-15
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

Colon cancer

Interventions

Enoxaparin group Subcutaneous injection of enoxaparin 2000U twice daily (postoperative day 2 to discharge) Intermittent pneumatic compression (IPC) prophylaxis (after surgery to postoperative day 1

Sponsors

Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age of 20 years or older 2. Peformance status: 0 or 1 3. Elective laparoscopic colon cancer surgery 4. Tumor location: C, A, T, D, S, RS 5. No distant metastases by preoperative image findings within 28 days before registration 6. No deep venos thrombosis by preoperative ultrasonography within 28 days before registration 7. No preoperative treatment ( radiation, chemotherapy, etc) 8. Written informed consent after receiving explanation of the study

Exclusion criteria

Exclusion criteria: 1. Cotraindications of enoxaparin -Allergy for enoxaparin, heparin, and heparin derivatives -Bleeding or bleeding suspected -Acute bacterial endocarditis -Severe renal dysfunction -History of heparin-induced thrombocytopenia (HIT) 2. History of VTE 3. Receiving anticoagulants or antiplatelet drugs 4. Allergy for contrast media 5. Petients who are considered to be inappropriate for this trial by doctor

Design outcomes

Primary

MeasureTime frame
Incidence of venos thromboembolism until postoperative day 28

Secondary

MeasureTime frame
1) Rate of bleeding events until discharge 2) Incidence of venos thromboembolism until discharge 3) Incidence of postoperative complications excluded venos thromboembolism

Countries

Japan

Contacts

Public ContactMitsuyoshi Ota

Yokohama City University Medical Center Gastroenerological Center

m_ota@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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