Trials / Unknown
UnknownNCT01589146
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.
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
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- University Of Perugia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Heparin, Low-Molecular-Weight | 4 weeks heparin prophylaxis |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2012-12-01
- First posted
- 2012-05-01
- Last updated
- 2012-05-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01589146. Inclusion in this directory is not an endorsement.