Short-term outcomes of laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): A multicenter, randomized, controlled trial.

Authors

null

Pan Chi

Fujian Medical University Union Hospital, Fuzhou, China

Pan Chi , Xiangqian Su , Jianmin Xu , Huizhong Qiu , Ziqiang Wang , Liang Kang , Haijun Deng , Weiping Chen , Qingtong Zhang , Xiaohui Du , Chunkang Yang , Yincong Guo , Ming Zhong , Kai Ye , Jun You , Dongbo Xu , Xinxiang Li , Zhiguo Xiong , Kaixiong Tao , Ke-Feng Ding

Organizations

Fujian Medical University Union Hospital, Fuzhou, China, Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Gastrointestinal Cancer Center, Peking University Cancer Hospital and Institute, Beijing, China, Department of General Surgery, Zhongshan Hospital Fudan University, Shanghai, China, Peking Union Medical College Hospital, Academy of Medical Sciences & Peking Union Medical College, Beijing, China, West China Hospital, Sichuan University, Chengdu, China, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, China, Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China, People's Liberation Army General Hospital, Beijing, China, Fujian Provincial Cancer Hospital, Fuzhou, China, Zhangzhou Affiliated Hospital, Fujian Medical University, Zhangzhou, China, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, The Second Affiliated Hospital, Fujian Medical University, Quanzhou, China, The First Affiliated Hospital, Xiamen University, Xiamen, China, Longyan Affiliated Hospital, Fujian Medical University, Longyan, China, Fudan University Shanghai Cancer Center, Shanghai, China, Hubei Provincial Cancer Hospital, Wuhan, China, Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Department of Colorectal Surgery and Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

Research Funding

Other Government Agency

Background: The efficacy of laparoscopic versus open surgery for low rectal cancer has not yet been established. We aimed to evaluate whether laparoscopic surgery is non-inferior to open surgery for low rectal cancer in terms of oncologic outcomes. Methods: LASRE trial (NCT01899547) is a multicenter, noninferiority, randomized controlled trial being conducted in 22 tertiary hospitals across China. Patients with low rectal cancer and without evidence of pelvic lateral lymph nodes or distant metastasis were randomly assigned (2:1) to laparoscopic or open surgery. The primary outcome was 3-year disease-free survival (DFS). Secondary outcomes included pathological outcomes, 30-day postoperative complications, 30-day mortality, overall survival (OS), and quality of life. The target sample size was 1065 patients. The short-term pathological, surgical, and postoperative recovery outcomes, analyzed in a modified intention-to-treat population (mITT). Results: Between November 12, 2013, and June 6, 2018, 1070 patients were randomized into laparoscopic (n = 712) or open surgery (n = 358) groups; 1039 were included in the mITT analysis (685 in laparoscopic and 354 in open group). Seventeen patients (2.5%) in the laparoscopic group required conversion to open surgery. There were no significant between-group differences in the rates of complete mesorectal excision (85.3% vs. 85.8%; p = 0.777), negative circumferential resection margins (98.2% vs. 99.7%; p = 0.085), negative distal resection margins (99.4% vs. 100%; p = 0.362), and numbers of retrieved lymph nodes (13.0 vs. 12.0; p = 0.394). The laparoscopic surgery group exhibited a shorter time to first flatus (40.4 vs. 44.8 hours; p = 0.006), time to first defecation (61.2 vs. 66.3 hours; p = 0.031), duration of analgesic use (45.0 vs. 48.0 hours; p = 0.001), and duration of hospitalization (8.0 vs. 9.0 days; p = 0.008) compared to the open surgery group. The postoperative complication rates were 13.0% and 17.2% in the laparoscopic and open surgery groups, respectively (p = 0.065). There was no incidence of 30-day mortality. Conclusions: In patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons can provide pathological outcomes comparable with those of open surgery in terms of complete mesorectal excision and negative resection margins, rapid postoperative recovery, and fewer postoperative complications. Clinical trial information: NCT01899547.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gastrointestinal Cancer—Colorectal and Anal

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Local-Regional Disease

Clinical Trial Registration Number

NCT01899547

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 3516)

DOI

10.1200/JCO.2022.40.16_suppl.3516

Abstract #

3516

Poster Bd #

310

Abstract Disclosures

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