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In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), a still unsolved issue is represented by intraoperative alveolar air leaks (IOAALs), which if prolonged beyond the fifth postoperative day can lead to higher risk of complications and higher medical costs. The polymeric hydrogel matrix (PHM) is a novel tool to manage intraoperative IOAALs. The primary end-point of our study was to verify whether PHM would be able to reduce postoperative air leaks; secondary end-points were the possible reduction of the permanence time of the chest drain (CD) and the hospital length (HL) in the PHM group compared with no treatment.
The management of postoperative air leaks remains an unresolved issue in pulmonary resections. This complication can be present in up to 75% of patients undergoing major lung resections; however, it often resolves spontaneously. In 8% of cases, air leaks can persist for up to 5-7 days post-surgery, and are associated with a higher risk of complications, such as prolonged chest tube duration, increased incidence of postoperative infections and higher medical and non-medical costs. Sealants are non-invasive medical devices that help reduce or eliminate air leaks and bleeding. A recent study showed an increased risk of air leaks in patients undergoing segmentectomies compared to lobar resections; this study is designed to evaluate the efficacy of intraoperative use of Polymeric Hydrogel matrix in achieving aerostasis during anatomical segmental pulmonary resections via VATS or RATS, compared to patients receiving standard of care. All patients meet the eligibility criteria and successfully undergo a minimally invasive segmentectomy will undergo intraoperative evaluation of alveolar air leaks. Those with moderate air leaks (30-60 ml/respiratory act, measured at the Ventilation Mechanical Test, which consists in 1 minute volumetric ventilation with a constant flow and a peak pressure of 22 cmH2O, 12 respiratory rates per minute and a positive end-expiratory pressure (PEEP) of 5 cmH2O), will be randomized to receive Polymeric Hydrogel matrix or no further treatment.The primary endpoint is to evaluate the efficacy in reducing postoperative air leaks secondary to the intraoperative application of Polymeric Hydrogel matrix (measured in days from the first postoperative day to the last day the air leaks are detected), compared to a control group receiving standard of care.The secondary endpoints include the evaluation of the postoperative permanence of chest tube, total length of hospital stay, medical and non-medical costs and postoperative complications up to 40 days of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymeric Hydrogel Matrix | Experimental | single application of Polymeric Hydrogel Matrix at the completion of lung resection, in patients with moderate intraoperative alveolar air leaks (30-60 ml/respiratory act), measured at the Ventilation Mechanical Test, which consists in 1 minute volumetric ventilation with a constant flow and a peak pressure of 22 cmH2O, 12 respiratory rates per minute and a positive end-expiratory pressure (PEEP) of 5 cmH2O. |
|
| Control Group | No Intervention | no further treatment at the completion of lung resection, in patients with moderate intraoperative alveolar air leaks (30-60 ml/respiratory act), measured at the Ventilation Mechanical Test, which consists in 1 minute volumetric ventilation with a constant flow and a peak pressure of 22 cmH2O, 12 respiratory rates per minute and a positive end-expiratory pressure (PEEP) of 5 cmH2O. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymeric Hydrogel Matrix | Device | application of Polymeric Hydrogel Matrix along the suture line at the completion of lung resection |
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| Measure | Description | Time Frame |
|---|---|---|
| presence of postoperative air leaks | The presence of postoperative air leaks from pleural drainage, from the end of surgery to the last day the air leaks are detected. | days from end of surgery up to 40 days of postoperative follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Chest drain length of stay | The duration of pleural drainage placement from the first postoperative day until the day of its removal | days from the first postoperative day up to 40 days of postoperative follow-up |
| In-Hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuele Nicotra, MDF | Thoracic Surgery Unit, University Hospital of Padua | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoracic Surgery Unit | Padua | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23590942 | Background | Fuller C. Reduction of intraoperative air leaks with Progel in pulmonary resection: a comprehensive review. J Cardiothorac Surg. 2013 Apr 16;8:90. doi: 10.1186/1749-8090-8-90. | |
| 29312730 | Background | Zaraca F, Vaccarili M, Zaccagna G, Maniscalco P, Dolci G, Feil B, Perkmann R, Bertolaccini L, Crisci R. Cost-effectiveness analysis of sealant impact in management of moderate intraoperative alveolar air leaks during video-assisted thoracoscopic surgery lobectomy: a multicentre randomised controlled trial. J Thorac Dis. 2017 Dec;9(12):5230-5238. doi: 10.21037/jtd.2017.11.109. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The length of hospital stay, measured from the first postoperative day until the patient is discharged from the hospital ward
| days from the first postoperative day up to 40 days of postoperative follow-up |
| Incidence of postoperative complications | Any complications arising in patients are recorded and assigned a severity grade according to the Clavien-Dindo classification. | days from the first postoperative day up to 40 days of postoperative follow-up |
| 31078312 | Background | Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9. |
| 40543008 | Derived | Nicotra S, Comacchio GM, Mammana M, Sambataro V, Pagliarini G, Bonis A, Boemo D, Bovo P, Rebusso A, Schiavon M, Cannone G, Faccioli E, Dell'Amore A, Rea F. Air leaks management using polymeric hydrogel matrix after thoracoscopic lung segmentectomy: a single-center prospective randomized trial with a cost-effective analysis. Updates Surg. 2026 Apr;78(2):953-959. doi: 10.1007/s13304-025-02291-1. Epub 2025 Jun 21. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |