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电视辅助胸腔镜手术肺叶切除术中密封剂对中度术中肺泡漏气管理影响的成本效益分析:一项多中心随机对照试验

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.

作者信息

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

机构信息

Department of Vascular and Thoracic Surgery, Regional Hospital, Bolzano, Italy.

Thoracic Surgery Unit, University of L'Aquila, G. Mazzini Hospital, Teramo, Italy.

出版信息

J Thorac Dis. 2017 Dec;9(12):5230-5238. doi: 10.21037/jtd.2017.11.109.

Abstract

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 (Progel) 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.

摘要

背景

术中肺泡漏气(IOAAL)是电视辅助胸腔镜手术(VATS)肺叶切除术后最常见的并发症之一。本研究旨在评估在中度IOAAL中,术中使用可生物降解的聚合物密封剂(Progel)是否能减少术后漏气(PAL),从而具有成本效益。

方法

在一项多中心试验中,将中度IOAAL患者随机分为术中使用密封剂组(密封剂组)或漏气标准处理组(对照组)。主要终点是术后漏气持续时间。次要结局包括:拔管时间、住院时间、术后2个月内的并发症以及成本分析。

结果

2015年1月至2017年1月期间,四个中心共进行了255例VATS肺叶切除术。55例符合纳入标准,被随机分配至密封剂组[28例]和对照组[27例]。两组之间的平均漏气持续时间有统计学差异(密封剂组=1.60天,对照组=5.04天;P<0.001)。密封剂组的平均引流时间(4.1天)明显短于对照组(6.74天)(P=0.008)。密封剂组的平均住院时间在统计学上较短(密封剂组=5.75天,对照组=7.85天;P=0.026)。密封剂组的成本有统计学意义的降低。

结论

在VATS肺叶切除术后的中度IOAAL中,可生物降解的聚合物密封剂安全有效。与标准治疗相比,密封剂显著减少了PAL、拔管时间和住院时间,从而带来显著的成本效益。

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