Prospective study of venous thromboembolism in patients with head and neck cancer after surgery: Interim analysis

Daniel Clayburgh, Will Stott, Teresa Kochanowski, Renee Park, Kara Detwiller, Maria Buniel, Paul Flint, Joshua Schindler, Peter Andersen, Mark Wax, Neil D. Gross

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)161-167
Number of pages7
JournalJAMA Otolaryngology - Head and Neck Surgery
Volume139
Issue number2
DOIs
StatePublished - Feb 2013

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Venous Thromboembolism
Head and Neck Neoplasms
Prospective Studies
Ultrasonography
Ambulatory Surgical Procedures
Pulmonary Embolism
Observational Studies
Thrombosis
Incidence
Diagnostic Imaging
Lower Extremity
Cohort Studies
Neck
Retrospective Studies
Head
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Otorhinolaryngology
  • Surgery

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Prospective study of venous thromboembolism in patients with head and neck cancer after surgery : Interim analysis. / Clayburgh, Daniel; Stott, Will; Kochanowski, Teresa; Park, Renee; Detwiller, Kara; Buniel, Maria; Flint, Paul; Schindler, Joshua; Andersen, Peter; Wax, Mark; Gross, Neil D.

In: JAMA Otolaryngology - Head and Neck Surgery, Vol. 139, No. 2, 02.2013, p. 161-167.

Research output: Contribution to journalArticle

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abstract = "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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