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

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, Liang Kang, Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group, 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, Liang Kang, Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group

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 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.

Conflict of interest statement

The authors report no conflicts of interest.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1
FIGURE 1
CONSORT flow diagram of patient enrollment and randomization. aSurgeons decided to perform the Miles operation for these patients according to the specific intraoperative circumstances. bPatients were found to have peritoneal metastasis (n=1) or liver metastasis (n=1) intraoperatively. cThe modified intent-to-treat set excluded patients who no longer met inclusion criteria after randomization. dThe 2 patients allocated to taTME did not receive proper consent; hence, no data could be used in any analysis. eAfter surgery, the patient refused to participate and have any data used in any analysis. CONSORT indicates Consolidated Standards of Reporting Trials.

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