Prevention of venous thromboembolism after laparoscopic surgery for colorectal cancer MedDRA version: 20.0 Level: LLT Classification code 10067650 Term: Pulmonary embolism prophylaxis System Organ Class: 100000004865 MedDRA version: 21.1 Level: LLT Classification code 10012108 Term: Deep venous thrombosis prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: XARELTO - 10 MG COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) 30 COMPRESSE
Product Name: Rivaroxaban
Product Code: [NA]
Pharmaceutical Form: Film-coated tablet
CAS Numb
Sponsors
FONDAZIONE FADOI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Objective diagnosis of Colorectal Cancer - Elective laparoscopic surgery for colorectal cancer - Whatever the stage of cancer - Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 446
Exclusion criteria
Exclusion criteria: - age < 18 years - surgery for non-cancer disease - duration of surgery < 45 min - Conversion to open surgery - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of postdischarge extended (3 weeks) antithrombotic prophylaxis with rivaroxaban compared to placebo after planned laparoscopic surgery for colorectal cancer in patients who had received antithrombotic prophylaxis with LMWH during the hospital stay for 7±2 days;Secondary Objective: To assess the efficacy and safety at 90 days of post-discharge extended (3 weeks) antithrombotic prophylaxis with rivaroxaban compared to placebo after planned laparoscopic surgery for colorectal cancer in patients who had received antithrombotic prophylaxis with LMWH during the hospital stay for 7±2 days;Primary end point(s): The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death at 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo. Pulmonary embolism will be diagnosed in the presence of: - intraluminal filling defect at computed tomography angiography or pulmonary angiography - high probability perfusion defect at perfusion lung scan with mismatch area compared to chest X Ray. Deep vein thrombosis will be diagnosed in the presence of: - an uncompressible vein segment in the deep vein of the lower limbs as assessed by complete compression ultrasonography examination;Timepoint(s) of evaluation of this end point: 28 days from surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo;; 2) symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 90 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo;Timepoint(s) of evaluation of this end point: 28 days from surgery; 90 days from surgery | — |
Countries
Italy
Contacts
Public ContactCentro Studi FADOI
Fondazione FADOI
Outcome results
None listed