Department of Thoracic Surgery, Barcelona University, Barcelona, Spain.
Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
J Surg Res. 2020 Sep;253:26-33. doi: 10.1016/j.jss.2020.03.023. Epub 2020 Apr 19.
A narrow-profile powered vascular stapler (PVS) was developed to provide superior access and precise staple placement in thoracic procedures. The objective of this study was to determine if the PVS would yield an equivalent rate of hemostatic interventions compared with standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy.
A randomized, controlled, multicenter study was conducted comparing PVS with SOC staplers in lobectomies performed for non-small cell lung cancer. The primary performance endpoint was the incidence of intraoperative hemostatic interventions, and the primary safety endpoint was the frequency of postoperative bleeding-related interventions.
A total of 98 subjects participated in the SOC group and 103 in the PVS group. Rates of intraoperative hemostatic interventions were 5.3% and 8.3% for the SOC and PVS groups, respectively. These rates were not statistically different (P = 0.137), although the upper bound of the 95% confidence interval for the difference in intervention rates between PVC and SOC exceeded a predefined 3% criterion for equivalence. Simple compressions were performed more frequently in the PVS subjects, which accounted for the higher intervention rate in this group. Postoperative interventions for bleeding were required in one SOC subject (1.0%) and one subject from the PVS group (0.9%). Procedure-related adverse events occurred in 21 (21.9%) SOC subjects and 23 (21.9%) PVS subjects, with no adverse events related to use of the study devices.
The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.
为了在胸科手术中提供更好的通道和更精确的吻合钉放置，开发了一种窄型电动吻合器（PVS）。本研究的目的是确定在电视辅助胸腔镜肺叶切除术中，PVS 是否与标准吻合器（SOC）相比，具有同等的止血干预率。
进行了一项随机、对照、多中心研究，比较了 PVS 与 SOC 吻合器在非小细胞肺癌行肺叶切除术中的应用。主要性能终点是术中止血干预的发生率，主要安全性终点是术后与出血相关的干预频率。
共有 98 例患者参加 SOC 组，103 例患者参加 PVS 组。SOC 组和 PVS 组术中止血干预的发生率分别为 5.3%和 8.3%。两组之间的干预率差异无统计学意义（P=0.137），但 PVC 和 SOC 之间干预率差异的 95%置信区间上限超过了预先设定的等效性 3%标准。在 PVS 组中，更频繁地进行简单的压迫，这导致了该组较高的干预率。SOC 组中有 1 例（1.0%）和 PVS 组中有 1 例（0.9%）需要进行术后出血干预。SOC 组有 21 例（21.9%）和 PVS 组有 23 例（21.9%）发生与手术相关的不良事件，无与研究器械使用相关的不良事件。
在电视辅助胸腔镜肺叶切除术中，PVS 与 SOC 吻合器的总体安全性和有效性相似。
