ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.

NCT ID: NCT01589146

Last Updated: 2012-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30

Brief Summary

Overall, only limited evidence exists regarding the clinical benefit of antithrombotic prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported incidence of VTE.

The aim of this multicenter, randomized study is to assess the clinical benefit of extended (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for colorectal cancer.

Conditions

The Primary Study Objective is to Assess the Efficacy and; Safety of Extended 4-week Heparin Prophylaxis Compared to; Prophylaxis Given for 8±2 Days After Planned Laparoscopic; Surgery for Colorectal Cancer.; The Clinical Benefit Will be Evaluated as the Difference in; the Incidence of VTE or VTE-related Death Occurring Within 30 Days; From Surgery in the Two Study Groups.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

short heparin

Group Type: NO_INTERVENTION

No interventions assigned to this group

extended heparin

Group Type: EXPERIMENTAL

Heparin, Low-Molecular-Weight

Intervention Type: DRUG

4 weeks heparin prophylaxis

Interventions

Heparin, Low-Molecular-Weight

4 weeks heparin prophylaxis

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Consecutive patients who had
• planned laparoscopic surgery for

Exclusion Criteria

• age < 18 years
• surgery for non-cancer disease
• duration of surgery < 45 min
• other indication for anticoagulant therapy
• known cerebral metastases
• kidney or liver failure
• known hemorrhagic diathesis or high risk for bleeding
• history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia
• pregnancy or lactation
• refusal of informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Cecilia Becattini

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Internal and Cardiovascular Medicine - University of Perugia

Perugia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Cecilia Becattini

Role: CONTACT

cecilia.becattini@unipg.it

+39 075 5786424

References

Vedovati MC, Becattini C, Rondelli F, Boncompagni M, Camporese G, Balzarotti R, Mariani E, Flamini O, Pucciarelli S, Donini A, Agnelli G. A randomized study on 1-week versus 4-week prophylaxis for venous thromboembolism after laparoscopic surgery for colorectal cancer. Ann Surg. 2014 Apr;259(4):665-9. doi: 10.1097/SLA.0000000000000340.

Reference Type: DERIVED

PMID: 24253138 (View on PubMed)

Other Identifiers

Unipg-CRU-01-2012

Identifier Type: -

Identifier Source: org_study_id