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  • Title: Efficacy and safety of TachoSil® versus standard treatment of air leakage after pulmonary lobectomy.
    Author: Marta GM, Facciolo F, Ladegaard L, Dienemann H, Csekeo A, Rea F, Dango S, Spaggiari L, Tetens V, Klepetko W.
    Journal: Eur J Cardiothorac Surg; 2010 Dec; 38(6):683-9. PubMed ID: 20541949.
    Abstract:
    OBJECTIVES: Alveolar air leakage remains a serious problem in lung surgery, being associated with increased postoperative morbidity, prolonged hospital stay and greater health-care costs. The aim of this study was to evaluate the sealing efficacy and safety of the surgical patch, TachoSil®, in lung surgery. METHODS: Patients undergoing elective pulmonary lobectomy who had grade 1 or 2 air leakage (evaluated by the water submersion test) after primary stapling and limited suturing were randomised at 12 European centres to open-label treatment with TachoSil® or standard surgical treatment (resuturing, stapling or no further treatment at the surgeons' discretion). Randomisation was performed during surgery using a centralised interactive voice response system. Duration of postoperative air leakage (primary end point), reduction of intra-operative air leakage intensity (secondary end point) and adverse events (AEs), including postoperative complications, were assessed. RESULTS: A total of 486 patients were screened and 299 received trial treatment (intent-to-treat (ITT) population: TachoSil®, n=148; standard treatment, n=151). TachoSil® resulted in a reduction in the duration of postoperative air leakage (p=0.030). Patients in the TachoSil® group also experienced a greater reduction in intra-operative air leakage intensity (p=0.042). Median time until chest drain removal was 4 days with TachoSil® and 5 days in the standard group (p=0.054). There was no difference between groups in hospital length of stay. AEs were generally similar in both groups, including postoperative complications. CONCLUSIONS: TachoSil® was superior to standard surgical treatment in reducing both postoperative air leakage duration and intra-operative air leakage intensity in patients undergoing elective pulmonary lobectomy.
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