ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. (PRO-LAPS I)

University Of Perugia

Status and phase

Unknown

Phase 3

Conditions

Safety of Extended 4-week Heparin Prophylaxis Compared to

the Incidence of VTE or VTE-related Death Occurring Within 30 Days

Surgery for Colorectal Cancer.

From Surgery in the Two Study Groups.

The Primary Study Objective is to Assess the Efficacy and

Prophylaxis Given for 8±2 Days After Planned Laparoscopic

The Clinical Benefit Will be Evaluated as the Difference in

Treatments

Drug: Heparin, Low-Molecular-Weight

Study type

Interventional

Funder types

Other

Identifiers

NCT01589146

Unipg-CRU-01-2012

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Consecutive patients who had
planned laparoscopic surgery for
colorectal cancer will be included in the study provided no exclusion criteria will be found

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.