Zaraca Francesco, Vaccarili Maurizio, Zaccagna Gino, Maniscalco Pio, Dolci Giampiero, Feil Birgit, Perkmann Reinhold, Bertolaccini Luca, Crisci Roberto
Department of Vascular and Thoracic Surgery, Regional Hospital Bolzano, Bolzano, Italy.
Department of Thoracic Surgery, University of L'Aquila, G. Mazzini Hospital, Teramo, Italy.
J Vis Surg. 2017 Dec 7;3:179. doi: 10.21037/jovs.2017.11.02. eCollection 2017.
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 (Progel 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 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 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 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.
我们在电视辅助胸腔镜手术(VATS)肺叶切除术后标准化了一种通气力学测试(VMT),该测试将术中肺泡气漏(IOAALs)分为轻度、中度和重度。我们认为轻度IOAALs(<100 mL/分钟)是自限性的,而重度IOAALs(>400 mL/分钟)必须进行治疗。IOAALs在100至400 mL/分钟之间被定义为中度,构成了一项前瞻性多中心随机试验的研究人群,该试验旨在研究在中度IOAAL情况下使用一种聚合生物可降解密封剂(Progel胸膜气漏密封剂,美国巴德戴维ol公司)与不治疗相比的效果。我们认为标准化的VMT能够准确选择需要治疗的患者,从而限制不必要的密封剂使用。我们分析了随机试验的数据,以评估Progel治疗在VMT选择的患者中的成本效益。这是一项多中心随机对照试验。中度IOAAL的患者被随机分为Progel组(A组)或“不治疗”组(B组)。该研究的主要疗效终点是术后漏气持续时间。次要结局指标包括:胸腔引流管拔除的平均时间、平均住院时间、术后两个月内发生并发症的百分比以及治疗费用。在2015年1月至2017年1月期间,4个中心共进行了255例VATS肺叶切除术,55例符合纳入标准,并被随机分配到2个不同的组(Progel组28例,对照组27例)。两组之间的平均漏气持续时间在统计学上有差异:A组为1.60天,B组为5.04天(P<0.001)。A组胸腔引流的平均持续时间在统计学上比对照组短(4.1天对6.74天;P=0.008)。A组的平均出院时间在统计学上也比B组短(5.75天对7.85天,P=0.026)。与对照组相比,Progel组的住院费用在统计学上有显著降低(Progel组=12,905英镑,对照组=39,690英镑;P<0.001)。我们的标准化VMT有助于缩短VATS肺叶切除术后的住院时间,因为在IOAALs为100至400 mL/分钟的情况下,与不治疗相比,使用ProgelTM可显著减少术后漏气、引流管拔除时间和住院时间。这种较短的住院时间带来了显著的成本节约效益。使用标准化VMT选择患者对于限制不必要的术中密封剂治疗至关重要,从而有助于控制成本。