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.
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- University Of Perugia
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
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.
Arms & Interventions
extended heparin
Intervention: Heparin, Low-Molecular-Weight (Drug)
Outcomes
Primary Outcomes
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Cecilia Becattini
MD
University Of Perugia