1. Morbidity, Mortality, and Pathologic Outcomes of Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial
- Author
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Huashan, Liu, Ziwei, Zeng, Hong, Zhang, Miao, Wu, Dan, Ma, Quan, Wang, Ming, Xie, Qing, Xu, Jun, Ouyang, Yi, Xiao, Yongchun, Song, Bo, Feng, Qingwen, Xu, Yanan, Wang, Yi, Zhang, Yuantao, Hao, Shuangling, Luo, Xingwei, Zhang, Zuli, Yang, Junsheng, Peng, Xiaojian, Wu, Donglin, Ren, Meijin, Huang, Ping, Lan, Weidong, Tong, Mingyang, Ren, Jianping, Wang, and Liang, Kang
- Abstract
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%; P0.99).Experienced surgeons can safely perform taTME in selected patients with rectal cancer.
- Published
- 2022