Ligasure与传统手术用于扩大胃癌切除术的随机临床试验。

Randomized clinical trial of Ligasure versus conventional surgery for extended gastric cancer resection.

作者信息

Lee W-J, Chen T-C, Lai I-R, Wang W, Huang M-T

机构信息

Department of Surgery, En-Chu Kong Hospital and National Taiwan University Hospital, Taipei, Taiwan, Republic of China.

出版信息

Br J Surg. 2003 Dec;90(12):1493-6. doi: 10.1002/bjs.4362.

DOI:10.1002/bjs.4362

PMID:14648726

Abstract

BACKGROUND

The Ligasure Vessel Sealing System is a haemostatic device designed primarily for use in abdominal surgery. Randomized trials have demonstrated that it is safe and quick for haemorrhoidectomy, but there is no evidence that it confers any advantage in complicated gastrointestinal surgery. The aim of the present study was to examine the value of the Ligasure system in extended lymph node dissection (D2) during gastrectomy for cancer in a randomized clinical trial.

METHODS

D2 gastric resection performed with the Ligasure system was compared with resection using conventional haemostatic methods in a prospective randomized trial. Central randomization (40 patients in each group) was performed after a staging laparotomy. The main outcome measures were operating time, intraoperative blood loss, postoperative course and complications.

RESULTS

Ligasure was associated with less intraoperative blood loss (mean(s.d.) 142(73) versus 239(124) ml; P = 0.001) and a shorter operating time (mean(s.d.) 169(25) versus 222(28) min; P = 0.001) than conventional operation. Postoperative drainage fluid volumes were greater in the Ligasure group (mean(s.d.) 1577(940) versus 886(542) ml; P = 0.020). There were no differences in postoperative complications or hospital stay.

CONCLUSION

The Ligasure Vessel Sealing System is safe for use in extended lymph node dissection for gastric cancer, and is associated with a shorter operating time and decreased blood loss compared with conventional haemostatic techniques.

摘要

背景

结扎速血管闭合系统是一种主要用于腹部手术的止血装置。随机试验表明，它用于痔切除术安全且快捷，但尚无证据表明其在复杂的胃肠手术中具有任何优势。本研究的目的是在一项随机临床试验中检验结扎速系统在胃癌胃切除术扩大淋巴结清扫（D2）中的价值。

方法

在一项前瞻性随机试验中，将使用结扎速系统进行的D2胃切除术与使用传统止血方法的切除术进行比较。在分期剖腹探查术后进行中心随机分组（每组40例患者）。主要观察指标为手术时间、术中出血量、术后病程及并发症。

结果

与传统手术相比，结扎速系统组术中出血量较少（均值（标准差）142（73）对239（124）ml；P = 0.001），手术时间较短（均值（标准差）169（25）对222（28）分钟；P = 0.001）。结扎速系统组术后引流量较多（均值（标准差）1577（940）对886（542）ml；P = 0.020）。术后并发症或住院时间无差异。