ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. (PRO-LAPS I)
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|ClinicalTrials.gov Identifier: NCT01589146|
Recruitment Status : Unknown
Verified April 2012 by Cecilia Becattini, University Of Perugia.
Recruitment status was: Recruiting
First Posted : May 1, 2012
Last Update Posted : May 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|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.||Drug: Heparin, Low-Molecular-Weight||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2012|
|No Intervention: short heparin|
|Experimental: extended heparin||
Drug: Heparin, Low-Molecular-Weight
4 weeks heparin prophylaxis
- symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589146
|Contact: Cecilia Becattini||+39 075 firstname.lastname@example.org|
|Internal and Cardiovascular Medicine - University of Perugia||Recruiting|