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

Phase 3

• 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.
• Interventions: Drug: Heparin, Low-Molecular-Weight

• Registration Number: NCT01589146
• Lead Sponsor: University Of Perugia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2012-04
• Study First Submitted: 2012-04-28
• Study First Submitted QC: 2012-04-28
• Last Update Submitted: 2012-04-28
• Study First Posted: 2012-05-01
• Last Update Posted: 2012-05-01
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
extended heparin	Heparin, Low-Molecular-Weight	-

Primary Outcome Measures

Name	Time	Method
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death	30 days

Trial Locations

Locations (1)

Internal and Cardiovascular Medicine - University of Perugia; 🇮🇹 Perugia, Italy