Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer
Authors: Zeng Ziwei , Luo Shuangling , 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 , Shi Lishuo , Ling Li , Zhang Xingwei , Huang Liang , Yang Zuli , Peng Junsheng , Wu Xiaojian , Ren Donglin , Huang Meijin , Lan Ping , Wang Jianping , Tong Weidong , Ren Mingyang , Liu Huashan , Kang Liang ,   Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group, Zheng Xiaobin , Liu Yanping , Huang Zijun , Hou Yujie , Liu Zhanzhen , Cai Yonghua , Lai Sicong , Hu Huanxin , Liu Ding-sheng , Cong Jin-chun , Peng Meng-yin , Liu Xian , Yang Xuan-hua , Zhou Dong-bing , Tian Yue , Ye Jing-wang , Zheng Hui-chao , Chen Guo-qing , Chen Jiang-hong , Li Meng , Zhang Jia-xin , Gong Yang , Wang Xing-qin , Xu Fu-jian , Li Zheng-biao , Gu Lei , Liu Ye , Zhan Ling , Zhang Yi-wen , Lu Jun-yang , Qian Jia-jia , Yang Rong , Tang Rui-xiang , Cai Zheng-hao , Xu Fei-peng , Fu Jie , Wu Ming-yi , Gao Kai 
Published: January 2025

Importance

Previous 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.

Objective

To evaluate 3-year disease-free survival between transanal TME and laparoscopic TME in patients with rectal cancer.

Design, Setting, and Participants

This 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.

Interventions

Participants 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 Measures

The 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.

Results

In 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 Relevance

In patients with mid-low rectal cancer, 3-year disease-free survival for transanal TME was noninferior to that of laparoscopic TME.

Trial Registration

ClinicalTrials.gov Identifier: NCT02966483