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血管闭合装置用于直径≤7mm血管的有效性:一项针对原发性肺癌患者胸腔镜肺叶切除术的随机对照试验

Usefulness of vessel-sealing devices for ≤7 mm diameter vessels: a randomized controlled trial for human thoracoscopic lobectomy in primary lung cancer.

作者信息

Toishi Masayuki, Yoshida Kazuo, Agatsuma Hiroyuki, Sakaizawa Takao, Eguchi Takashi, Saito Gaku, Hashizume Masahiro, Hamanaka Kazutoshi, Shiina Takayuki

机构信息

Department of Thoracic Surgery, Shinshu University School of Medicine, Matsumoto, Japan.

Department of Thoracic Surgery, Shinshu University School of Medicine, Matsumoto, Japan

出版信息

Interact Cardiovasc Thorac Surg. 2014 Sep;19(3):448-55. doi: 10.1093/icvts/ivu176. Epub 2014 Jun 3.

Abstract

OBJECTIVES

Vessel-sealing devices (VSDs) are widely used for various surgical procedures, including thoracoscopic surgery, but very few reports have compared their safety and usefulness with human thoracoscopic lobectomy procedures not employing VSDs.

METHODS

Primary lung cancer patients for whom a thoracoscopic lobectomy involving mediastinal lymph node dissection was planned in our department from April 2011 to March 2013 were recruited for the study. Patients were randomly allocated to a control group (n = 14) or a VSD group (n = 44), which comprised three sub-groups, namely EnSeal (n = 17), LigaSure (n = 15) and Harmonic (n = 12). The control group comprised patients undergoing surgery solely with ligation and conventional electrocautery. EnSeal, LigaSure and Harmonic were chosen because they are the three most popular disposable VSDs used in Japan. In the VSD groups, the proximal side of pulmonary artery stumps (≤7 mm diameter) were ligated and then treated with respective devices. Primary end-points were burst pressure of the pulmonary artery stump (measured using resected specimens), operative time, intraoperative blood loss, instances of endostapler use, intraoperative surgeon stress (assessed by visual analogue scale) and postoperative drainage volume and duration. As a secondary objective, the individual VSD groups were also compared with each other.

RESULTS

The burst pressure of ligation-treated pulmonary artery stumps was higher than that of VSD-treated stumps (P <0.0001). The burst pressure of <5-mm-wide VSD-treated stumps was higher than that of ≥5-mm-wide stumps (P = 0.0421). However, the burst pressure for all groups and all vessel diameters was sufficient to withstand the physiological pulmonary artery pressure. The VSD group demonstrated reduced intraoperative blood loss (P = 0.0241), surgeon stress (P = 0.0002), postoperative drainage volume (P = 0.0358) and shortened postoperative drainage duration (P = 0.0449). Operative time and the instances of endostapler use did not significantly differ. Comparison between each of the VSD groups revealed no significant differences. None of the patients experienced serious perioperative complications or died because of surgery.

CONCLUSION

VSD is simple and safe to use in thoracoscopic lobectomy involving mediastinal lymph node dissection for primary lung cancer. Furthermore, none of the VSDs used in this study presented any observable differences in quality that could lead to clinical problems.

摘要

目的

血管闭合装置(VSD)广泛应用于包括胸腔镜手术在内的各种外科手术,但很少有报告将其与未使用VSD的人类胸腔镜肺叶切除术的安全性和实用性进行比较。

方法

招募2011年4月至2013年3月在我科计划进行包括纵隔淋巴结清扫的胸腔镜肺叶切除术的原发性肺癌患者进行研究。患者被随机分配到对照组(n = 14)或VSD组(n = 44),VSD组包括三个亚组,即EnSeal组(n = 17)、LigaSure组(n = 15)和Harmonic组(n = 12)。对照组患者仅接受结扎和传统电灼手术。选择EnSeal、LigaSure和Harmonic是因为它们是日本使用最广泛的三种一次性VSD。在VSD组中,结扎肺动脉残端近端(直径≤7mm),然后用相应装置处理。主要终点是肺动脉残端的破裂压力(使用切除标本测量)、手术时间、术中失血、吻合器使用情况、术中外科医生压力(通过视觉模拟评分评估)以及术后引流量和持续时间。作为次要目标,还对各个VSD组进行了相互比较。

结果

结扎处理的肺动脉残端破裂压力高于VSD处理的残端(P <0.0001)。宽度<5mm的VSD处理的残端破裂压力高于宽度≥5mm的残端(P = 0.0421)。然而,所有组和所有血管直径的破裂压力足以承受生理性肺动脉压力。VSD组术中失血减少(P = 0.0241)、外科医生压力降低(P = 0.0002)、术后引流量减少(P = 0.0358)且术后引流持续时间缩短(P = 0.0449)。手术时间和吻合器使用情况无显著差异。各VSD组之间的比较未发现显著差异。所有患者均未发生严重围手术期并发症或因手术死亡。

结论

在涉及原发性肺癌纵隔淋巴结清扫的胸腔镜肺叶切除术中,VSD使用简单且安全。此外,本研究中使用的任何VSD在质量上均未表现出可导致临床问题的明显差异。

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