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单孔腹腔镜胆囊切除术与不良事件增加相关:一项随机对照试验的荟萃分析结果。

Single-incision laparoscopic cholecystectomy is responsible for increased adverse events: results of a meta-analysis of randomized controlled trials.

机构信息

Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy.

Department of Surgical Sciences, University of Perugia, Terni, Italy.

出版信息

Surg Endosc. 2018 Sep;32(9):3739-3753. doi: 10.1007/s00464-018-6143-y. Epub 2018 Mar 9.

DOI:10.1007/s00464-018-6143-y
PMID:29523982
Abstract

BACKGROUND

Over the last decade, single-incision laparoscopic cholecystectomy (SLC) has gained popularity, although it is not evident if benefits of this procedure overcome the potential increased risk. Aim of the study is to compare the outcome of SLC with conventional multi-incision laparoscopic cholecystectomy (MLC) in a meta-analysis of randomized controlled trials only.

METHODS

A systematic Medline, Embase, and Cochrane Central Register of Controlled Trials literature search of articles on SLC and MLC for any indication was performed in June 2017. The main outcomes measured were overall adverse events, pain score (VAS), cosmetic results, quality of life, and incisional hernias. Linear regression was used to model the effect of each procedure on the different outcomes.

RESULTS

Forty-six trials were included and data from 5141 participants were analysed; 2444 underwent SLC and 2697 MLC, respectively. Mortality reported was nil in both treatment groups. Overall adverse events were higher in the SLC group (RR 1.41; p < 0.001) compared to MLC group, as well severe adverse events (RR 2.06; p < 0.001) and even mild adverse events (RR 1.23; p = 0.041). This was confirmed also when only trials including 4-port techniques (RR 1.37, p = 0.004) or 3-port techniques were considered (RR 1.89, p = 0.020). The pain score showed a standardized mean difference (SMD) of - 0.36 (p < 0.001) in favour of SLC. Cosmetic outcome by time point scored a SMD of 1.49 (p < 0.001) in favour of SLC. Incisional hernias occurred more frequently (RR 2.97, p = 0.005) in the SLC group.

CONCLUSIONS

Despite SLC offers a better cosmetic outcome and reduction of pain, the consistent higher rate of adverse events, both severe and mild, together with the higher rate of incisional hernias, should suggest to reconsider the application of single incision techniques when performing cholecystectomy with the existing technology.

摘要

背景

在过去的十年中,单切口腹腔镜胆囊切除术(SLC)已经越来越受欢迎,尽管这种手术的益处是否超过了潜在的风险增加还不太清楚。本研究的目的是仅通过随机对照试验的荟萃分析来比较 SLC 和传统多切口腹腔镜胆囊切除术(MLC)的结果。

方法

我们对 2017 年 6 月发表的关于 SLC 和 MLC 的所有适应证的 Medline、Embase 和 Cochrane 对照试验中心注册库文献进行了系统的检索。主要观察指标是总不良事件、疼痛评分(VAS)、美容效果、生活质量和切口疝。线性回归用于模拟每种手术对不同结局的影响。

结果

共纳入 46 项试验,分析了 5141 名参与者的数据;分别有 2444 名患者接受 SLC,2697 名患者接受 MLC。两组均无死亡报告。与 MLC 组相比,SLC 组的总不良事件发生率更高(RR 1.41;p<0.001),严重不良事件发生率(RR 2.06;p<0.001)甚至轻度不良事件发生率(RR 1.23;p=0.041)更高。当仅考虑包括 4 孔技术(RR 1.37,p=0.004)或 3 孔技术(RR 1.89,p=0.020)的试验时,也得到了同样的结果。疼痛评分显示 SLC 组的标准化均数差(SMD)为-0.36(p<0.001)。美容结局在时间点上的 SMD 为 1.49(p<0.001),有利于 SLC。SLC 组切口疝的发生率更高(RR 2.97,p=0.005)。

结论

尽管 SLC 提供了更好的美容效果和减轻疼痛,但由于严重和轻度不良事件的发生率持续较高,加上切口疝的发生率较高,在使用现有技术进行胆囊切除术时,应重新考虑应用单切口技术。

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