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对比经肛全直肠系膜切除术与腹腔镜全直肠系膜切除术:一项多中心III期随机临床试验(TaLaR试验)方案

查看全文 作　　者：Liang [1,2,3]Kang;Ziwei [1,2,3]Zeng;Shuangling [1,2,3]Luo;Hong [4]Zhang;Quan [5]Wang;Mingyang [6]Ren;Miao [7]Wu;Weidong [8]Tong;Qing [9]Xu;Yi [10]Xiao;Aiwen [11]Wu;Yuan-Guang [12]Chen;Bo [13]Feng;Zhanlong [14]Shen;Liang [1,2,3]Huang;Xingwei [1,2,3]Zhang;Minhua [13]Zheng;Jian-Ping [1,2,3]Wang 高影响力作者 机构地区：[1]Department of Colorectal Surgery,The Sixth Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong,P.R.China;[2]Guangdong Institute of Gastroenterology,The Sixth Affiliated Hospital of Sun Yatsen University,Guangzhou,Guangdong,P.R.China;[3]Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases,The Sixth Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong,P.R.China;[4]Department of Colorectal Surgery,Shengjing Hospital of China Medical University,Shenyang,Liaoning,P.R.China;[5]Department of Gastrointestinal Surgery,The First Hospital of Jilin University,Changchun,Jilin,P.R.China;[6]Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical College,Nanchong,Sichuan,P.R.China;[7]Department of Gastrointestinal Surgery,The Second People’s Hospital of Yibin,Yibin,Sichuan,P.R.China;[8]Department of General Surgery,Daping Hospital,Army Medical university,Chongqing,P.R.China;[9]Department of Gastrointestinal Surgery,Renji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,P.R.China;[10]Department of General Surgery,Peking Union Medical College Hospital,Peking Union Medical College and Chinese Academy of Medical Sciences,Beijing,P.R.China;[11]Department of Gastrointestinal Surgery,Peking University Cancer Hospital,Beijing,P.R.China;[12]Department of Gastrointestinal Surgery,The First Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong,P.R.China;[13]Ruijin Hospital Shanghai Jiaotong University School of Medicine,Shanghai,P.R.China;[14]Department of Gastrointestinal Surgery,Peking University People’s Hospital,Beijing,P.R.China高影响力机构 出　　处：《Gastroenterology Report》索引2021年第9卷第1期,共7页高影响力期刊 基　　金：supported by a grant from Fundamental Research Funds for the Central Universities[Grant No.16ykjc25 addressed to L.K.];the Sun Yat-sen University Clinical Research 5010 Program[Grant No.2016005 addressed to L.K.]. 摘　　要：背景:全直肠系膜切除术是直肠癌治疗的标准手术方法。经肛全直肠系膜切除术(taTME)是治疗低位直肠癌的新术式。既往研究表明,与腹腔镜全直肠系膜切除术(lapTME)相比,taTME应用于低位直肠癌患者可提供更高质量的手术标本,但其长期肿瘤学结果仍需进一步观察。因此,我们设计了这个非劣效性临床试验(TaLaR试验),比较taTME与lapTME治疗直肠癌的短期和长期结果。方法/设计:TaLaR试验是一项多中心III期随机对照试验。研究对象为经磁共振成像、直肠指检或结肠镜检查被诊断为位于腹膜反折以下的直肠癌,若肿瘤分期≤cT3N2直接手术,若>cT3N2则先行新辅助治疗。通过计算,本研究需纳入1,114例患者(每组557例)。纳入病例随机分配到taTME或lapTME组。本研究的主要终点是3年无病生存率(DFS)和5年总生存率(OS)。次要终点包括手术标本质量、围手术期结果、骨盆和肛门功能以及生活质量。讨论:我们认为,TaLaR试验将阐明taTME是否可以达到与lapTME相似的肿瘤学结果,以及是否可改善直肠癌患者的手术标本质量及恢复情况。 关 键 词：transanal total mesorectal excision total mesorectal excision LAPAROSCOPIC rectal cancer SURGERY
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