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.
Conditions
Keywords
colon-rectal cancer, heparin, prophylaxis, laparoscopy
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.
Interventions
4 weeks heparin prophylaxis
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death | 30 days |
Countries
Italy
Contacts
Primary ContactCecilia Becattini
Outcome results
None listed