常规甲状腺切除术应用 Harmonic ACE 超声刀与 LigaSure Precise 血管闭合系统治疗甲状腺微小乳头状癌的手术效果比较：一项单盲前瞻性随机对照研究。

Comparison of surgical outcomes between papillary thyroid cancer patients treated with the Harmonic ACE scalpel and LigaSure Precise instrument during conventional thyroidectomy: a single-blind prospective randomized controlled trial.

机构信息

Department of Surgery, College of Medicine, Catholic University of Korea, Seoul St Mary's Hospital, Seoul, Republic of Korea.

Department of Medical Life Sciences, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.

出版信息

J Surg Res. 2014 Apr;187(2):484-9. doi: 10.1016/j.jss.2013.11.1093. Epub 2013 Nov 22.

DOI:10.1016/j.jss.2013.11.1093

PMID:24332551

Abstract

BACKGROUND

The aim of this study was to evaluate the safety and efficacy of thyroidectomy using the Harmonic ACE scalpel (HS) or the LigaSure Precise (LS) instrument in conventional thyroidectomy.

MATERIALS AND METHODS

A prospective, randomized controlled trial was performed. Between August 2011 and June 2012, 832 patients who required thyroidectomy for papillary thyroid cancer were randomized into groups treated with either the HS or the LS instrument. Operative time and surgical morbidities were analyzed.

RESULTS

A total of 320 patients (HS group, N = 164; LS instrument group, N = 156) were randomized for analysis according to the intention-to-treat principle. There were no statistically significant differences in the operative times (HS group versus LS instrument group: 71.93 ± 18.26 versus 75.15 ± 20.13; P = 0.423), postoperative transient hypoparathyroidism (13.4% versus 14.1%; P = 0.858), and permanent recurrent laryngeal nerve injuries between the two groups.

CONCLUSIONS

In this study, both hemostatic devices were safe and effective in terms of postoperative results and complications without any differences.

摘要

背景

本研究旨在评估在常规甲状腺切除术（conventional thyroidectomy）中使用 Harmonic ACE 刀（HS）或 LigaSure Precise（LS）仪器进行甲状腺切除术的安全性和有效性。

材料与方法

进行了一项前瞻性、随机对照试验。2011 年 8 月至 2012 年 6 月期间，832 例因甲状腺乳头状癌需要甲状腺切除术的患者被随机分为使用 HS 或 LS 仪器治疗的两组。分析了手术时间和手术并发症。

结果

根据意向治疗原则，共有 320 例患者（HS 组，N=164；LS 仪器组，N=156）被随机分配进行分析。两组的手术时间（HS 组与 LS 仪器组：71.93±18.26 与 75.15±20.13；P=0.423）、术后暂时性甲状旁腺功能减退症（13.4%与 14.1%；P=0.858）和永久性喉返神经损伤无统计学差异。