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

NCT01589146 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-05-01

No results posted yet for this study

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.

Interventions

DRUG

Heparin, Low-Molecular-Weight

4 weeks heparin prophylaxis

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589146 on ClinicalTrials.gov