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Morbidity, Mortality, and Pathologic Outcomes of Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial

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机构: [1]Department of Colorectal Surgery and Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China. [2]Department of Colorectal Surgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China. [3]Department of Gastrointestinal Surgery, The Second People's Hospital of Yibin, Yibin, Sichuan Province, China. [4]Department of General Surgery, Xinqiao Hospital, Army Medical University, Chongqing, China. [5]Department of Gastrointestinal Surgery, The First Hospital of Jilin University, Changchun, Jilin Province, China. [6]Department of Gastrointestinal Surgery, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou Province, China. [7]Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. [8]Department of Gastrointestinal Surgery, The First Affiliated Hospital of University of South China, Hengyang, Hunan Province, China. [9]Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. [10]Department of Gastrointestinal Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xian, Shanxi Province, China. [11]Department of Gastrointestinal Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. [12]Department of Gastrointestinal Surgery, The Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong Province, China. [13]Department of Gastrointestinal Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong Province, China. [14]Department of Gastrointestinal Surgery, The Third Xiangya Hospital of Central South University, Changsha, Hunan Province, China. [15]Sun Yat-sen Global Health Institute, Sun Yat-sen University, Guangzhou, Guangdong Province, China. [16]Department of General Surgery, Daping Hospital, Army Medical University, Chongqing, China. [17]Department of Gastrointestinal Surgery, The Affiliated Nanchong Central Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China.
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关键词: rectal cancer taTME morbidity mortality

摘要:
To determine the morbidity, mortality, and pathologic outcomes of transanal total mesorectal resection (taTME) versus laparoscopic total mesorectal excision (laTME) among patients with rectal cancer with clinical stage I to III rectal cancer below the peritoneal reflection.Studies with sufficient numbers of patients allowing clinical acceptance of taTME for rectal cancer are lacking. Thus, we launched a randomized clinical trial to compare the safety and efficacy of taTME versus laTME.A randomized, open-label, phase 3, noninferiority trial was performed at 16 different hospitals in 10 Chinese provinces. The primary endpoints were 3-year disease-free survival and 5-year overall survival. The morbidity and mortality within 30 days after surgery, and pathologic outcomes were compared based on a modified intention-to-treat principle; this analysis was preplanned.Between April 13, 2016, and June 1, 2021, 1115 patients were randomized 1:1 to receive taTME or laTME. After exclusion of 26 cases, modified intention-to-treat set of taTME versus laTME groups included 544 versus 545 patients. There were no significant differences between taTME and laTME groups in intraoperative complications [26 (4.8%) vs 33 (6.1%); difference, -1.3%; 95% confidence interval (CI), -4.2% to 1.7%; P=0.42], postoperative morbidity [73 (13.4%) vs 66 (12.1%); difference, 1.2%; 95% CI, -2.8% to 5.2%; P=0.53), or mortality [1 (0.2%) vs 1 (0.2%)]. Successful resection occurred in 538 (98.9%) versus 538 (98.7%) patients in taTME versus laTME groups (difference, 0.2%; 95% CI, -1.9% to 2.2%; P>0.99).Experienced surgeons can safely perform taTME in selected patients with rectal cancer.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

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大类 | 1 区 医学
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大类 | 1 区 医学
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第一作者机构: [1]Department of Colorectal Surgery and Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.
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通讯机构: [1]Department of Colorectal Surgery and Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China. [*1]Department of Colorectal Surgery and Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510655, China.
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