• Ziwei Zeng, Shuangling Luo, 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, Lishuo Shi, Li Ling, Xingwei Zhang, Liang Huang, Zuli Yang, Junsheng Peng, Xiaojian Wu, Donglin Ren, Meijin Huang, Ping Lan, Jianping Wang, Weidong Tong, Mingyang Ren, Huashan Liu, Liang Kang, and Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group.
• Department of General Surgery (Colorectal Surgery), Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
• JAMA. 2025 Jan 23.

ImportancePrevious studies have demonstrated the advantages of short-term histopathological outcomes and complications associated with transanal total mesorectal excision (TME) compared with laparoscopic TME. However, the long-term oncological outcomes of transanal TME remain ambiguous. This study aims to compare 3-year disease-free survival of transanal TME with laparoscopic TME.ObjectiveTo evaluate 3-year disease-free survival between transanal TME and laparoscopic TME in patients with rectal cancer.Design, Setting, And ParticipantsThis randomized, open-label, noninferiority, phase 3 clinical trial was performed in 16 different centers in China. Between April 2016 and June 2021, a total of 1115 patients with clinical stage I to III mid-low rectal cancer were enrolled. The last date of participant follow-up was in June 2024.InterventionsParticipants were randomly assigned in a 1:1 ratio before their surgical procedure to undergo either transanal TME (n = 558) or laparoscopic TME (n = 557).Main Outcomes And MeasuresThe primary end point was 3-year disease-free survival, with a noninferiority margin of -10% for the comparison between transanal TME and laparoscopic TME. Secondary outcomes included 3-year overall survival and 3-year local recurrence.ResultsIn the primary analysis set, the median patient age was 60 years. A total of 692 male and 397 female patients were included in the analysis. Three-year disease-free survival was 82.1% (97.5% CI, 78.4%-85.8%) for the transanal TME group and 79.4% (97.5% CI, 75.6%-83.4%) for the laparoscopic TME group, with a difference of 2.7% (97.5% CI, -3.0% to 8.1%). The lower tail of a 2-tailed 97.5% CI for the group difference in 3-year disease-free survival was above the noninferiority margin of -10 percentage points. Furthermore, the 3-year local recurrence was 3.6% (95% CI, 2.0%-5.1%) for transanal TME and 4.4% (95% CI, 2.6%-6.1%) for laparoscopic TME. Three-year overall survival was 92.6% (95% CI, 90.4%-94.8%) for transanal TME and 90.7% (95% CI, 88.3%-93.2%) for laparoscopic TME.Conclusions And RelevanceIn patients with mid-low rectal cancer, 3-year disease-free survival for transanal TME was noninferior to that of laparoscopic TME.Trial RegistrationClinicalTrials.gov Identifier: NCT02966483.

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