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使用LigaSure进行甲状腺切除术与传统血管结扎术的前瞻性临床试验:系统评价与荟萃分析

Prospective clinical trials of thyroidectomy with LigaSure vs conventional vessel ligation: a systematic review and meta-analysis.

作者信息

Yao Hou Shan, Wang Qiang, Wang Wei Jun, Ruan Can Ping

机构信息

Department of General Surgery, Shanghai Chang Zheng Hospital, Second Military Medical University, Shanghai 200003, China.

出版信息

Arch Surg. 2009 Dec;144(12):1167-74. doi: 10.1001/archsurg.2009.201.

Abstract

OBJECTIVE

To evaluate the hemostatic effects and safety of thyroidectomy performed using the LigaSure vessel-sealing device (Valleylab, Boulder, Colorado) or the conventional vessel ligation.

DATA SOURCES

The MEDLINE, EMBASE, Elsevier, SpringerLink, Ovid, and Cochrane Library electronic databases as well as the LigaSure manufacturer's Web site were searched for studies published between 1996 and 2008. No language restrictions were applied.

STUDY SELECTION

Prospective, controlled clinical trials, both randomized and nonrandomized, comparing the hemostatic effects and safety of thyroidectomy using LigaSure and conventional vessel ligation were selected.

DATA EXTRACTION

Data regarding operative parameters, duration of the operation, amount of intraoperative blood loss, length of hospital stay, and any postoperative complications were entered and analyzed using dedicated software from the Cochrane Collaboration.

DATA SYNTHESIS

Four randomized and 5 nonrandomized trials that met selection criteria reported data from 927 patients, of whom 467 (50.4%) underwent LigaSure and 460 (49.6%) underwent conventional thyroidectomy. Operative duration (weighted mean difference [WMD], -11.97 minutes; 95% confidence interval [CI], -16.42 to -7.53 minutes) was significantly reduced with LigaSure thyroidectomy (P < .001). When LigaSure was used, operative time reductions of 20.32 minutes (95% CI, -33.86 to -6.79 minutes) for total thyroidectomy (P = .003) and 21.74 minutes (-38.32 to -5.16 minutes) for subtotal thyroidectomy (P = .01) were also confirmed with subgroup analysis. However, differences in the amount of intraoperative blood loss (WMD, -25.13 mL; 95% CI, -68.45 to 18.18 mL; P = .26), length of hospital stay (WMD, -0.08 days; 95% CI, -0.23 to 0.08 days; P = .31), and postoperative complication rates (odds ratio, 0.91; 95% CI, 0.61-1.04; P = .65) were not statistically significant for LigaSure vs conventional thyroidectomy.

CONCLUSIONS

The LigaSure technique may provide a safe, effective, and fast alternative to conventional vessel ligation in thyroidectomy and may result in a significant reduction in operative duration. However, it may not confer any advantage over conventional thyroidectomy in terms of the amount of intraoperative blood loss, length of hospital stay, and postoperative complication rates.

摘要

目的

评估使用LigaSure血管闭合装置(美国科罗拉多州博尔德市Valleylab公司生产)或传统血管结扎法进行甲状腺切除术的止血效果及安全性。

资料来源

检索MEDLINE、EMBASE、爱思唯尔、施普林格在线、Ovid及考克兰图书馆电子数据库以及LigaSure制造商网站,查找1996年至2008年发表的研究。未设语言限制。

研究选择

选取前瞻性对照临床试验,包括随机和非随机试验,比较使用LigaSure和传统血管结扎法进行甲状腺切除术的止血效果及安全性。

资料提取

使用考克兰协作网的专用软件录入并分析有关手术参数、手术时长、术中失血量、住院时间及任何术后并发症的数据。

资料综合

4项随机试验和5项非随机试验符合入选标准,报告了927例患者的数据,其中467例(50.4%)接受LigaSure甲状腺切除术,460例(49.6%)接受传统甲状腺切除术。LigaSure甲状腺切除术使手术时长显著缩短(加权均数差[WMD],-11.97分钟;95%置信区间[CI],-16.42至-7.53分钟;P <.001)。亚组分析还证实,对于全甲状腺切除术,使用LigaSure时手术时间缩短20.32分钟(95% CI,-33.86至-6.79分钟;P =.003);对于次全甲状腺切除术,手术时间缩短21.74分钟(-38.32至-5.16分钟;P =.01)。然而,LigaSure组与传统甲状腺切除术组在术中失血量(WMD,-25.13 mL;95% CI,-68.45至18.18 mL;P =.26)、住院时间(WMD,-0.08天;95% CI,-0.23至0.08天;P =.31)及术后并发症发生率(比值比,0.91;95% CI,0.61 - 1.04;P =.65)方面差异无统计学意义。

结论

在甲状腺切除术中,LigaSure技术可能是一种安全、有效且快速的传统血管结扎替代方法,可显著缩短手术时长。然而,在术中失血量、住院时间及术后并发症发生率方面,它可能并不比传统甲状腺切除术更具优势。

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