Objectives: To prospectively determine the incidence of venous thromboembolism (VTE) following major head and neck surgery. At the midpoint of enrollment, an interim analysis was performed to determine if it was ethical to continue this study as an observational study without routine anticoagulation. Design: Prospective, observational cohort study. Setting: Academic surgical center. Patients: The interim analysis comprised 47 subjects. Main Outcome Measure: The total number of new cases of VTE (superficial and deep) identified within 30 days of surgery and confirmed on diagnostic imaging. These cases were further categorized as clinically relevant and nonclinically relevant. Clinically relevant VTEs were those requiring more than 6 weeks of anticoagulation or were associated with any negative impact on clinical course. On postoperative day 2 or 3, subjects were clinically examined and received duplex ultrasonography. Subjects with negative findings from examination and ultrasonography were followed up clinically; subjects with evidence of deep venous thrombus or pulmonary embolism were given therapeutic anticoagulation. Subjects with superficial VTE received repeated ultrasonography on postoperative days 4 to 6. Subjects were monitored for 30 days after surgery. Results: Three subjects (6%) were identified as having clinically significant VTE: 2 cases of deep venous thrombus and 1 case of pulmonary embolism. Two additional subjects had lower extremity superficial VTE without clinical findings, which were detected by ultrasonography alone. No statistically significant differences were seen between patients with VTE and those without VTE. Conclusions: This interim analysis of the first prospective study of the incidence of VTE in patients with head and neck cancer showed a VTE rate slightly higher than previously estimated in retrospective studies. There have been no unexpected serious adverse events and no rationale for early termination of the study.
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