中国经肛全直肠系膜切除术后吻合口漏发生情况及其危险因素:基于全国协作研究数据库的回顾性分析  

Incidence and risk factors of anastomotic leak after transanal total mesorectal excision in China:a retrospective analysis based on national database

作　　者：顾磊[1] 安勇博 任明扬[3] 王权[4] 张宏宇[5] 于刚 陈建志 吴淼[8] 肖毅[9] 傅志聪 张宏[11] 童卫东 马丹 徐庆[1] 姚宏伟[2] 张忠涛[2] Gu Lei;An Yongbo;Ren Mingyang;Wang Quan;Zhang Hongyu;Yu Gang;Chen Jianzhi;Wu Miao;Xiao Yi;Fu Zhicong;Zhang Hong;Tong Weidong;Ma Dan;Xu Qing;Yao Hongwei;Zhang Zhongtao(Department of Gastrointestinal Surgery,Renji Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200127,China;Department of General Surgery,Beijing Friendship Hospital,Capital Medical University Beijing Key Laboratory of Cancer Invasion and Metastasis Research&National Clinical Research Center for Digestive Diseases,Beijing 100050,China;Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical College,Nanchong 637900,Sichuan Province,China;Department of Gastrointestinal Surgery,The First Hospital of Jilin University,Changchun 130021,China;Department of Gastrointestinal Surgery,The First Affiliated Hospital of Chongqing Medical University,Chongqing 400042,China;Department of Gastrointestinal Surgery,Linzi People's Hospital,Linzi 255200,Shandong Province,China;Department of Surgery,Koo Foundation,Sun Yat-sen Cancer Center,Taipei,Taiwan 112,China;Department of Gastrointestinal Hernial Surgery,Yibin Second People's Hospital,Yibin 644000,Sichuan Province,China;Department of General Surgery,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China;Department of Surgery,Mary Hospital,Hong Kong 999077,China;Department of Colorectal Cancer,Shengjing Hospital,China Medical University,Shenyang 110004,China;Department of General Surgery,Daping Hospital,Army Medical University,Chongqing 400042,China;Department of General Surgery,Xinqiao Hospital,Army Medical University,Chongqing 400037,China)

机构地区：[1]上海交通大学医学院附属仁济医院胃肠外科,200127 [2]首都医科大学附属北京友谊医院普通外科,国家消化系统疾病临床医学研究中心,100050 [3]川北医学院南充中心医院胃肠外科,四川南充637900 [4]吉林大学第一医院胃肠外科,长春130021 [5]重庆医科大学附属第一医院胃肠外科,400042 [6]山东省临淄市人民医院结直肠外科,255200 [7]台北和信治癌中心医院外科,中国台湾112 [8]四川省宜宾市第二人民医院胃肠疝外科,644000 [9]中国医学科学院,北京协和医学院,北京协和医院基本外科,100730 [10]玛丽医院外科,中国香港999077 [11]中国医科大学附属盛京医院结直肠肿瘤外科,沈阳110004 [12]陆军军医大学大坪医院普通外科,重庆400042 [13]陆军军医大学新桥医院普通外科,重庆400037

出　　处：《中华胃肠外科杂志》2021年第6期505-512,共8页Chinese Journal of Gastrointestinal Surgery

基　　金：国家自然科学基金面上项目(82072671);上海交通大学转化医学交叉研究基金重点项目(ZH2018ZDA08);国家科技支撑计划课题(2015BAI13B09);北京市临床重点专科基金(卓越项目2018-118);北京市医院管理局临床医学发展专项基金(ZYLX201504);首都医科大学附属北京友谊医院科研启动基金(YYQDKT2016-5)。

摘　　要：目的经肛全直肠系膜切除术(taTME)自开展以来经历了最初的欣喜狂热到后来的冷静反思阶段,充满争议。而挪威卫生部叫停taTME,其原因之一就是较高的术后吻合口漏发生率。本研究通过统计中国taTME病例登记协作研究(CTRC)数据库中的病例资料,了解我国taTME术后吻合口漏的发生情况,并进行危险因素分析。方法采用病例对照研究方法,回顾性收集2017年11月15日至2020年12月31日期间,CTRC数据库中来自全国43家中心的1668例taTME手术患者的临床病例资料,排除未行消化道重建的98例患者以及术后并发症资料不完整的109例患者,1461例患者纳入分析;男性1036例(70.9%),女性425例(29.1%);年龄(58.2±15.6)岁;体质指数(23.6±3.8)kg/m2。根据国际直肠癌研究组(ISREC)严重程度分级标准定义吻合口漏及其严重程度,统计taTME术后发生吻合口漏的情况;分析术后吻合口漏的危险因素;评估单中心累计taTME手术例数的多少对发生吻合口漏的影响,了解taTME手术登记数≥40例的高流量中心在taTME开展初期的20例与近期开展的20例发生吻合口漏的情况并进行比较。结果本组1461例接受taTME手术的患者发生吻合口漏103例(7.0%)。其中男性71例(68.9%),女性32例(31.1%);年龄(59.0±13.9)岁;体质指数(24.5±5.7)kg/m2;吻合口距肛缘(2.6±1.4)cm;ISREC A级39例(37.9%),B级30例(29.1%),C级34例(33.0%)。腹腔镜辅助taTME(Lap-taTME)组发生吻合口漏89例(7.0%,89/1263),单纯经肛taTME(pure-taTME)组14例(7.1%,14/198)。taTME术后吻合口漏发生的多因素分析结果显示,未使用吻合器吻合(P=0.004)和未行预防性造口(P=0.013)为taTME术后发生吻合口漏的独立危险因素。taTME手术登记数≥30例的中心有16个(37.2%),taTME手术累计例数1317例,发生吻合口漏86例(6.5%);而<30例的中心有27个,累计手术144例,发生吻合口漏17例(11.8%),两者比较,差异有统计学意义(χ2=5.513,P=0.019)。taTME手术登记数≥40�Objective Transanal total mesorectal excision(taTME)was a very hot topic in the first few years since its appearance,but now more introspections and controversies on this procedure have emerged.One of the reasons why the Norwegian Ministry of Health stopped taTME was the high incidence of postoperative anastomotic leak.In current study,the incidence and risk factors of anastomotic leak after taTME were analyzed based on the data registered in the Chinese taTME Registry Collaborative(CTRC).Methods A case-control study was carried out.Between November 15,2017 and December 31,2020,clinical data of 1668 patients undergoing taTME procedure registered in the CTRC database from 43 domestic centers were collected retrospectively.After excluding 98 cases without anastomosis and 109 cases without complete postoperative complication data,1461 patients were finally enrolled for analysis.There were 1036 males(70.9%)and 425 females(29.1%)with mean age of(58.2±15.6)years and mean body mass index of(23.6±3.8)kg/m2.Anastomotic leak was diagnosed and classified according to the International Study Group of Rectal Cancer(ISREC)criteria.The risk factors associated with postoperative anastomotic leak cases were analyzed.The impact of the cumulative number of taTME surgeries in a single center on the incidence of anastomotic leak was evaluated.As for those centers with the number of taTME surgery≥40 cases,incidence of anastomic leak between 20 cases of taTME surgery in the early and later phases was compared.Results Of 1461 patients undergoing taTME,103(7.0%)developed anastomotic leak,including 71(68.9%)males and 32(31.1%)females with mean age of(59.0±13.9)years and mean body mass index of(24.5±5.7)kg/m2.The mean distance between anastomosis site and anal verge was(2.6±1.4)cm.Thirty-nine cases(37.9%)were classified as ISREC grade A,30 cases(29.1%)as grade B and 34 cases(33.0%)as grade C.Anastomotic leak occurred in 89 cases(7.0%,89/1263)in the laparoscopic taTME group and 14 cases(7.1%,14/198)in the pure taTME group.Multivariat

关 键 词：直肠肿瘤 经肛全直肠系膜切除术 中国经肛全直肠系膜切除病例登记协作研究 并发症 吻合口漏 危险因素 

分 类 号：R735.37[医药卫生—肿瘤]