Francesco Petrella1, Alessandro Borri2, Daniela Brambilla2, Giorgio Calanca3, Nicola Vezzani3, Antonio Colantoni4, Adolfo Gasparetto4, Lorenzo Spaggiari5. 1. Department of Thoracic Surgery, European Institute of Oncology, Milan, Italy. Electronic address: francesco.petrella@ieo.it. 2. Department of Thoracic Surgery, European Institute of Oncology, Milan, Italy. 3. Enable Innovations s.r.l, Modena, Italy. 4. Nextrasearch s.a.s, Padua, Italy. 5. Department of Thoracic Surgery, European Institute of Oncology, Milan, Italy; Department of Oncology and Hematology-Oncology-DIPO, University of Milan, Milan, Italy.
Abstract
BACKGROUND: Prolonged air leak is one of the most common complications after lung surgery and the cause of prolonged hospital stay frequently associated with major postoperative morbidity and thus responsible for even higher hospital costs. This case-control study was designed to test the sealing efficacy and safety of Enable-Innoseal TP4 in patients undergoing pulmonary resection for lung cancer. METHODS: This was a case-control trial enrolling patients with primary or single site metastatic lung cancer scheduled for elective anatomic or nonanatomic pulmonary resection presenting intraoperative grade 1 or 2 air leak at water submersion test; the study group population was then matched 1:1 according to surgical procedure, male/female ratio, preoperative FEV1, and age. RESULTS: In the study population, 21 patients (70.0%) presented intraoperative grade 1 air leak and 9 patients grade 2 (30.0%) air leak; after comparison with the control group, we observed a significant shorter time for chest drain removal in the study population (P = 0.0050), whereas no difference was registered in terms of number of days needing for discharge (P = 0.0762). CONCLUSIONS: Enable-Innoseal TP4 was effective in treating limited intraoperative air leaks after pulmonary resection and preventing prolonged postoperative air leaks in patients receiving either anatomic or nonanatomic lung resections. Further randomized double-arm studies are required to confirm the efficacy of Enable-Innoseal TP4 demonstrated by this pilot study.
BACKGROUND: Prolonged air leak is one of the most common complications after lung surgery and the cause of prolonged hospital stay frequently associated with major postoperative morbidity and thus responsible for even higher hospital costs. This case-control study was designed to test the sealing efficacy and safety of Enable-Innoseal TP4 in patients undergoing pulmonary resection for lung cancer. METHODS: This was a case-control trial enrolling patients with primary or single site metastatic lung cancer scheduled for elective anatomic or nonanatomic pulmonary resection presenting intraoperative grade 1 or 2 air leak at water submersion test; the study group population was then matched 1:1 according to surgical procedure, male/female ratio, preoperative FEV1, and age. RESULTS: In the study population, 21 patients (70.0%) presented intraoperative grade 1 air leak and 9 patients grade 2 (30.0%) air leak; after comparison with the control group, we observed a significant shorter time for chest drain removal in the study population (P = 0.0050), whereas no difference was registered in terms of number of days needing for discharge (P = 0.0762). CONCLUSIONS: Enable-Innoseal TP4 was effective in treating limited intraoperative air leaks after pulmonary resection and preventing prolonged postoperative air leaks in patients receiving either anatomic or nonanatomic lung resections. Further randomized double-arm studies are required to confirm the efficacy of Enable-Innoseal TP4 demonstrated by this pilot study.
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