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

作者：Liu, Huashan; Zeng, Ziwei; Zhang, Hong; Wu, Miao; Ma, Dan; Wang, Quan; Xie, Ming; Xu, Qing; Ouyang, Jun; Xiao, Yi; Song, Yongchun; Feng, Bo; Xu, Qingwen; Wang, Yanan; Zhang, Yi; Hao, Yuantao; Luo, Shuangling; Zhang, Xingwei; Yang, Zuli; Peng, Junsheng; Wu, Xiaojian; Ren, Donglin; Huang, Meijin; Lan, Ping; Tong, Weidong; Ren, Mingyang; Wang, Jianping; Kang, Liang^*

来源：Annals of Surgery, 2023, 277(1): 1-6.

DOI：10.1097/SLA.0000000000005523

• rectal cancer
• taTME
• morbidity
• mortality

Objective: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. Background: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. Methods: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. Results: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). Conclusions:Experienced surgeons can safely perform taTME in selected patients with rectal cancer.

• 单位
  吉林大学; 广东医学院; 中山大学; 上海交通大学; 中国医科大学; 中国医学科学院; 中国医学科学院北京协和医院; 南方医科大学; 西安交通大学; 6; 1