背景:在这项研究中,我们探讨了在单孔电视胸腔镜手术(VATS)上肺叶切除术中,与传统的两个胸管相比,一个胸膜导管加单个胸管引流是否可以达到非劣质引流效果。
方法:在2020年1月至11月接受上肺叶切除术的患者被纳入这个单中心,随机化,开放标签,非劣效性试验。在关闭之前,患者被随机分为干预组,该干预组接受了改良的引流策略,包括一根胸膜导管和一根胸管(24Fr),对照组采用传统双胸管引流术。
结果:共有390名患者进入研究,尽管190例患者因改变非单孔手术入路或选择非肺叶切除术而被排除。最后,将200例患者随机分组(干预组100例,对照组100例)。两组之间的基线人口统计学和临床特征具有可比性。术后第1天,干预组和对照组的气胸发生率相似(非劣效性,10%vs.13%,p=0.658)。此外,次要结局如第30天气胸发生率、术后胸管/胸膜导管拔除时间等无显著差异,第1天的排水量,手术后的总排水量,或术后住院。干预组疼痛评分明显降低(3.33±0.68vs.3.68±0.94,p=0.003)。
结论:上肺叶切除术后的新策略不亚于双胸管引流术,可以更好地控制疼痛,建议采用单通道胸腔镜进行上叶切除术。
In this
study we explored whether one pleural catheter plus single chest tube drainage could achieve a noninferior drainage effect when compared with the traditional two chest tubes in uniportal video-assisted thoracoscopic surgery (VATS) for an upper pulmonary lobectomy.
Patients that underwent an upper pulmonary lobectomy from January to November 2020 were enrolled in this single-center, randomized, open-label, noninferiority
trial. Prior to closure, patients were randomized to an intervention group who received an improved drainage strategy involving one pleural catheter with one chest tube (24 Fr), while traditional double chest tube drainage was applied for the control group.
A total of 390 patients entered the
study, although 190 were excluded for changing nonuniportal surgical approaches or opting for nonlobectomy resections. Finally, 200 patients were randomized (100 in the intervention group and 100 in the control group). The baseline demographic and clinical characteristics were comparable between the groups. The incidence of pneumothorax in the intervention and control groups was similar on postoperative Day 1 (noninferiority, 10% vs. 13%, p = 0.658). In addition, there were no significant differences in secondary outcomes such as incidence of pneumothorax by Day 30, postoperative chest tube/pleural catheter removal time, amount of drainage on Day 1, total amount of drainage after operation, or postoperative hospitalization. A significantly lower pain score was observed in the intervention group (3.33 ± 0.68 vs. 3.68 ± 0.94, p = 0.003).
The new strategy is noninferior to double chest tube drainage after an upper pulmonary lobectomy offers superior pain control, and is recommended for an upper lobectomy by uniportal VATS.