Morbidity, Mortality, and Pathologic Outcomes of Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial. Issue 1 (11th January 2023)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Annals of surgery. Volume 277:Issue 1(2023)
• Page Start: 1
• Page End: 6
• Publication Date: 2023-01-11
• Subjects: rectal cancer -- taTME -- morbidity -- mortality; Surgery -- Periodicals; 617.005
• DOI: 10.1097/SLA.0000000000005523
• Languages: English
• ISSNs: 0003-4932

Abstract

Abstract : 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 intention­to­treat 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 intention­to­treat 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.