Antonio M, Pietra T, Domenico Lg, Massimo D, Ignazio R, Antonio N, Luigi C
Department of Experimental Oncology and Clinical Application, Faculty of Medicine and Surgery, University of Palermo, Palermo, Italy.
Ecancermedicalscience. 2007;1:61. doi: 10.3332/eCMS.2007.61. Epub 2007 Nov 29.
Axillary lymph node dissection (ALND) is an integral part of breast cancer treatment. It is required in about 40-50% of patients. The placement of a drain in the axilla after an operation is current surgical practice. Short surgical stay programmes increase operating efficiency and reduce medical care costs, without compromising quality of care. LigaSure(™) is a new haemostatic device that uses bipolar energy to seal vessels. The aim of this study is to determine whether axillary dissection with LigaSure(™) reduces the time of wound drainage, the duration of surgical intervention and the volume of drainage after treatment.
This study is a prospective randomized controlled trial. A total of 100 women with breast cancer who needed axillary dissection were randomized into the LigaSure(™) or conventional axillary dissection group. Levels I to III lymph node dissection was performed. A closed suction drain was always placed in the axilla and removed after 6-8 days or when fluid amount was <60 cc in the previous 24 hours.
THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS WHEN CONSIDERING THE DURATION OF SURGICAL PROCEDURE: average duration was 70.7 ± 24.66 minutes for LigaSure(™) patients, while in the conventional dissection group the mean was 70.6 ± 22.47 minutes (p=0.98). Total amount of drained fluid was 624.49 cc in the LigaSure(™) axillary dissection group and 792.96 in the conventional ALND group; this difference did not achieve statistical significance (p=0.09); the duration of draining was also similar, with no statistical difference (p=0.15).
The present study did not show clear advantages in LigaSure(™) use for ALND, although it represents a good haemostatic device, especially in abdominal surgery.
腋窝淋巴结清扫术（ALND）是乳腺癌治疗的一个重要组成部分。约40%-50%的患者需要进行该手术。术后在腋窝放置引流管是当前的手术操作规范。短期手术住院方案可提高手术效率并降低医疗成本，同时不影响医疗质量。LigaSure（™）是一种新型止血设备，它利用双极能量封闭血管。本研究的目的是确定使用LigaSure（™）进行腋窝清扫术是否能减少伤口引流时间、手术干预时长以及治疗后的引流量。
本研究是一项前瞻性随机对照试验。共有100例需要进行腋窝清扫术的乳腺癌女性患者被随机分为LigaSure（™）组或传统腋窝清扫组。进行了Ⅰ至Ⅲ级淋巴结清扫。腋窝常规放置闭式负压引流管，在6-8天后或前24小时引流量<60 cc时拔除。
在考虑手术时长时，两组之间无显著差异：LigaSure（™）组患者的平均手术时长为70.7±24.66分钟，而传统清扫组的平均时长为70.6±22.47分钟（p=0.98）。LigaSure（™）腋窝清扫组的总引流量为624.49 cc，传统ALND组为792.96 cc；这一差异未达到统计学显著性（p=0.09）；引流时长也相似，无统计学差异（p=0.15）。
本研究未显示出LigaSure（™）用于ALND有明显优势，尽管它是一种良好的止血设备，尤其在腹部手术中。
