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

From Surgery in the Two Study Groups. Clinical Trial

Official title: ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms
• From Surgery in the Two Study Groups.
• Prophylaxis Given for 8±2 Days After Planned Laparoscopic
• Safety of Extended 4-week Heparin Prophylaxis Compared to
• 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
• The Primary Study Objective is to Assess the Efficacy and

• NCT number: NCT01589146
• Study type: Interventional
• Source: University Of Perugia
• Contact: Cecilia Becattini
• Phone: +39 075 5786424
• Email: cecilia.becattini@unipg.it
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2010