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评估电动外科吻合器在电视辅助胸腔镜肺切除术中临床性能的前瞻性临床研究。

Prospective Clinical Study to Evaluate Clinical Performance of a Powered Surgical Stapler in Video-assisted Thoracoscopic Lung Resections.

作者信息

Licht Peter B, Ribaric Goran, Crabtree Traves, Lanuti Michael, Molins Laureano, Knippenberg Susan, Schwiers Michael, Yoo Andrew

机构信息

Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.

Johnson & Johnson, Hamburg, Germany.

出版信息

Surg Technol Int. 2015 Nov;27:67-75.

PMID:26680381
Abstract

Video-assisted thoracic surgery (VATS) research often focuses on postoperative air leak, with special consideration for prolonged air leak. There is limited clinical data regarding how stapling devices might affect performance and postoperative outcomes, including air leak. This prospective research evaluates intraoperative and postoperative data associated with VATS, using a new surgical stapling device, in two different geographic regions (the U.S. and Europe). A total of 226 subjects across 10 institutions were enrolled in this study. The primary endpoint was occurrence and duration of postoperative air leaks, including prolonged air leak. Additional data collected included intraoperative details and postoperative outcomes. Prolonged air leak occurred in 22 subjects (10.3%) across procedures (152 lobectomies, 63 wedge resections, and 11 occurrences of wedge resection plus lobectomy). There were no significant differences in occurrence or duration of PAL between the U.S. and Europe. Regional differences were observed for intraoperative leak testing and cartridge selection relative to tissue type. Despite differences in surgical technique between continents, no major or significant difference in air leak or other clinical outcome was detected. Additional research is needed to characterize optimal cartridge selection to tissue properties and how these may potentially impact clinical outcomes.

摘要

电视辅助胸腔镜手术(VATS)研究通常聚焦于术后漏气,尤其是持续性漏气。关于缝合器械如何影响手术操作及术后结果(包括漏气)的临床数据有限。这项前瞻性研究在两个不同地理区域(美国和欧洲)使用一种新型手术缝合器械,评估与VATS相关的术中及术后数据。来自10个机构的226名受试者参与了本研究。主要终点是术后漏气的发生情况及持续时间,包括持续性漏气。收集的其他数据包括术中细节和术后结果。在所有手术(152例肺叶切除术、63例楔形切除术以及11例楔形切除术加肺叶切除术)中,22名受试者(10.3%)出现了持续性漏气。美国和欧洲在持续性漏气的发生率或持续时间上没有显著差异。在术中漏气检测以及根据组织类型选择钉仓方面观察到了区域差异。尽管各大洲之间手术技术存在差异,但在漏气或其他临床结果方面未检测到重大或显著差异。需要进一步研究来确定针对组织特性的最佳钉仓选择,以及这些选择如何可能影响临床结果。

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