系统评价预防性造口、术前放疗和肠系膜下动脉结扎水平对直肠癌术后吻合口漏发生的影响

Meta.analysis for high-risk factor of anastomotic leakage after anal-preserving surgery for rectal cancer

目的系统评价预防性造口、术前放疗和肠系膜下动脉结扎水平对直肠癌术后吻合口漏发生率的影响。方法计算机系统检索Pubmed、Embase、Scopus、CochraneLibrary、中国知网和万方数据库（自创刊日期至2017年12月止）中，公开发表的关于预防性造口、术前放疗和肠系膜下动脉结扎水平与直肠癌术后吻合口漏发生关系的随机对照研究（RCT）；同时检索临床试验注册数据库（clinieahrials．gov）查找研究尚未发表但数据已公布的研究。严格按照标准筛选文献后，进行文献质量评估并提取数据资料：采用Reviewmanager5．3软件对数据进行Meta分析，采用以DerSimonian and Laird的方法学为基础的随机固定效应模型，并使用χ^2检验评估各研究间存在的异质性。结果20篇文献的7004例患者纳入研究，吻合口漏总发生率为7．0％（488例）。预防性造口组459例，未预防性造口组445例，吻合口漏发生率分别为5．2％（24例）和17．3％（77例）；术前放疗组2900例，未术前放疔组2946例，吻合口漏发生率分别为6．5％（188例）和6．1％（179例）；低位结扎组129例，高位结扎组125例，吻合口漏发生率分别为4．7％（6例）和11．2％（14例）。Meta分析结果显示，与未进行预防性造口相比，预防性造口患者术后吻合口漏发生率明显降低（RR：0．33，95％CI：0．21～0．50，P〈0．00001）；术前放疗组和未行术前放疗组患者术后吻合口漏发生率的差异无统计学意义（RR：1．05，95％CI：0．80～1．38，P=0．72）；低位结扎组与高位结扎组患者的术后吻合El漏发生率差异无统计学意义（RR：0．50，95％CI：0．20—1．23，P=0．13）。有关预防性造口和术前放疗RCT研究分别绘制的漏斗图较对称，无明显发表偏倚。结论预防性造口能够有效预防直肠癌术后吻合口漏的发生，而术前放疗和高位结扎可能不会额外增加吻合口漏的风险。

Objective To systematically evaluate the effect of defunctioning stoma, preoperative radiotherapy, and level of inferior mesenteric artery （IMA） ligation on the postoperative anastomotic leakage in rectal cancer by meta-analysis. Methods Randomized controlled trials （RCT） published before December 2017 regarding the effects of defunctioning stoma, preoperative radiotherapy, and level of inferior mesenteric artery ligation on the postoperative anastomotic leakage in rectal cancer were searched from PubMed, Embase, Scopus, Coehrane Library, CNKI, Wanfang database, meanwhile open data in unpublished trials from clinicahrials.gov were retrieved. Associated data were screened according to standard and their quality was evaluated strictly. Review manager 5.3 software was used to perform meta-analysis with data. Random effect model based on DerSimonian and Laird method was applied. Heterogenicity among trials was estimated with Chi-square test. Results Twenty articles were included in the meta-analysis. The overall incidence of anastomotie leakage was 7.0% （488/7004）. The incidence of anastomotic leakage in the defunctioning stoma group and non-defunetioning stoma group was 5.2%（24/459） and 17.3%（77/445） respectively. The incidence of anastomotic leakage in the radiotherapy group and non-radiotherapy group was 6.5% （188/2900） and 6.1% （179/2946） respectively. The incidences of anastomotie leakage in the low and high IMA ligation groups was 4.7% （6/129） and 11.2% （14/125） respectively. Meta-analysis showed that the incidence in defunetioning stoma group was significantly lower than that in non-defunctioning stoma group （RR： 0.33, 95%CI：0.21 - 0.50, P 〈 0.000 01）; the incidences between radiotherapy group and non- radiotherapy （RR：I.05, 95%C1：0.80 - 1.38, P = 0.72）, and between low IMA ligation group and high IMA ligation group （RR：0.50, 95%CI：0.20 - 1.23, P = 0.13） were not significantly different. Funnel figure drawn with RCTs about defunetioning stoma and preoperative radiotherapy revealed no significant publication bias existed within included studies. Conclusion Defunctioning stoma can effectively prevent the occurrence of postoperative anastomotic leakage, whereas the preoperative radiotherapy and high IMA ligation may not increase the risk of anastomotic leakage.