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Transanal vs laparoscopic total mesorectal excision for rectal cancer: a multicenter randomized phase III clinical trial (TaLaR trial) protocol.

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机构: [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 YatsenUniversity, Guangzhou, Guangdong, P. R. China [3]Guangdong Provincial Key Laboratory of Colorectal andPelvic 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 CentralHospital of North Sichuan Medical College, Nanchong, Sichuan, P. R. China [7]Department of GastrointestinalSurgery, 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 ofGeneral Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academyof Medical Sciences, Beijing, P. R. China [11]Department of Gastrointestinal Surgery, Peking University CancerHospital, Beijing, P. R. China [12]Department of Gastrointestinal Surgery, The First Affiliated Hospital ofGuangzhou Medical University, Guangzhou, Guangdong, P. R. China [13]Ruijin Hospital Shanghai JiaotongUniversity School of Medicine, Shanghai, P. R. China [14]Department of Gastrointestinal Surgery, PekingUniversity People’s Hospital, Beijing, P. R. China
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关键词: transanal total mesorectal excision total mesorectal excision laparoscopic rectal cancer surgery

摘要:
Total mesorectum excision (TME) is considered the standard surgical procedure for rectal-cancer treatment. Transanal TME (taTME) is a new procedure to treat low rectal cancer. Some published studies have proven that taTME can provide a better-quality resected specimen in low-rectal-cancer patients in comparison to the transabdominal procedure, yet long-term outcomes must be investigated. We designed this non-inferiority trial (TaLaR trial) to compare short-term and long-term outcomes between taTME and laparoscopic TME (lapTME) for rectal cancer. The TaLaR trial is a phase III open-labeled multicenter randomized-controlled trial. Patients who are diagnosed with rectal cancer with no more than T3N2 stage, and with the tumor location below the peritoneal reflection by magnetic resonance imaging scan, digital rectal examination, or colonoscopy, qualify for this study. After calculating, a total of 1,114 patients (557 per group) will be randomly allocated to either the taTME or the lapTME group. Primary endpoints are the 3-year disease-free survival (DFS) rate and the 5-year overall survival (OS) rate. Secondary endpoints include specimen quality, perioperative results, pelvic and anal function, and quality of life. The TaLaR trial is expected to clarify whether taTME can achieve comparable oncological outcomes, as well as improve specimen quality and recovery conditions in rectal-cancer patients compared with lapTME. © The Author(s) 2020. Published by Oxford University Press and Sixth Affiliated Hospital of Sun Yat-sen University.

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出版当年[2021]版:
大类 | 3 区 医学
小类 | 3 区 胃肠肝病学
最新[2023]版:
大类 | 3 区 医学
小类 | 4 区 胃肠肝病学
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出版当年[2021]版:
Q2 GASTROENTEROLOGY & HEPATOLOGY
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Q2 GASTROENTEROLOGY & HEPATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者:
第一作者机构: [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 YatsenUniversity, Guangzhou, Guangdong, P. R. China [3]Guangdong Provincial Key Laboratory of Colorectal andPelvic Floor Diseases, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R.China
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通讯机构: [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 YatsenUniversity, Guangzhou, Guangdong, P. R. China [3]Guangdong Provincial Key Laboratory of Colorectal andPelvic Floor Diseases, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R.China [13]Ruijin Hospital Shanghai JiaotongUniversity School of Medicine, Shanghai, P. R. China [*1]Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, 200025, P. R. China [*2]The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510655, P. R. China
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