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

Francesco Zaraca, Maurizio Vaccarili, Gino Zaccagna, Pio Maniscalco, Giampiero Dolci, Birgit Feil, Reinhold Perkmann, Luca Bertolaccini, Roberto Crisci


Background: Intraoperative alveolar air leak (IOAAL) is one of most common complications after video-assisted thoracoscopic surgery (VATS) lobectomy. The study aimed to evaluate if, in moderate IOAAL, intraoperative polymeric biodegradable sealant (ProgelTM) reduced postoperative air leak (PAL) and consequently was cost-effective.
Methods: Patients with moderate IOAAL were randomised in a multicentre trial to intraoperative use of a sealant (Sealant group) or standard management of air leaks (Control group). Primary endpoint was the postoperative duration of air leakage. Secondary outcomes included: time to drainage removal, length of hospital stay, postoperative complications within 2 months, and cost analysis.
Results: Between January 2015 and January 2017, 255 VATS lobectomies were performed in four centres. Fifty-five met inclusion criteria and were randomly assigned to Sealant group [28] and Control group [27]. The mean air leakage duration was statistically different between groups (Sealant group =1.60 days, Control group =5.04 days; P<0.001). The average length of drainage was significantly (P=0.008) shorter in Sealant group (4.1 days) than in Controls (6.74 days). The mean time of hospital stay was statistically shorter in sealant group (Sealant =5.75 days, Control =7.85 days; P=0.026). Sealant group observed a statistically significant reduction of costs.
Conclusions: In moderate IOAAL after VATS lobectomy, polymeric biodegradable sealants are safe and efficient. Compared with standard treatments, sealant significantly reduces PAL, time to drain removal and length of hospital stay resulting in significant costs benefits.