Can a standardised Ventilation Mechanical Test for quantitative intraoperative air leak grading reduce the length of hospital stay after video-assisted thoracoscopic surgery lobectomy?

We standardised a Ventilation Mechanical Test (VMT) after video-assisted thoracoscopic surgery (VATS) lobectomy that classifies intraoperative alveolar air leaks (IOAALs) in mild, moderate and severe. We assumed that mild IOAALs (<100 mL/min) are self-limiting, whereas severe IOAALs (>400 mL/min) must be treated. An IOAAL between 100 and 400 mL/min was defined moderate and constituted the study population of a prospective multicentre randomised trial on the use of a polymeric biodegradable sealant (ProgelTM Pleural Air Leak Sealant, Bard Davol, USA) in case of moderate IOAAL compared with no treatment. We assumed that the standardised VMT allows to accurately selected patients needing treatment, thus limiting unnecessary sealant use. We analysed data of the randomised trial to assess the cost-effectiveness of Progel treatment in VMT selected patients. This is a multicenter randomised controlled trial. Patients with moderate IOAAL were randomised to Progel (group A) or "no treatment" (group B).The primary efficacy endpoint of the study was the postoperative duration of air leakage. The secondary outcome measures included: mean time to chest drain removal, mean length of hospitalisation, the percentage of postoperative complications occurring within two months, and cost of treatment. Between January 2015 and January 2017, 255 VATS lobectomies were performed in 4 centres, 55 met the inclusion criteria, and they were randomly assigned to 2 different groups (28 in the Progel and 27 in the control group). The mean air leakage duration was statistically different between the two groups: in the group A was 1.60 vs. 5.04 days in group B (P<0.001). The average duration of chest drainage was statistically shorter in group A than in the control group (4.1 vs. 6.74 days; P=0.008). The mean time to hospital discharge was also statistically shorter in group A than in group B (5.75 vs. 7.85 days, P=0.026). In the Progel group, a statistically significant reduction of hospitalisation costs compared with the control group was observed (Progel group =12,905₤, Control group =39,690₤; P<0.001). Our standardised VMT helps in reducing the length of hospital stay after VATS lobectomy because in case of IOAALs between 100 and 400 mL/min the use of ProgelTM significantly reduces postoperative air leak, time to drain removal and length of hospitalisation compared with no treatment. This shorter hospital stays results in significant cost saving benefits. Selection of patients with standardised VMT is essential to limit unnecessary intraoperative sealant treatments, thus contributing to limit the costs.

RCT Entities:   Population Interventions Outcomes