Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer
Authors: Jiang Wei-Zhong , Xu Jian-Min , Xing Jia-Di , Qiu Hui-Zhong , Wang Zi-Qiang , Kang Liang , Deng Hai-Jun , Chen Wei-Ping , Zhang Qing-Tong , Du Xiao-Hui , Yang Chun-Kang , Guo Yin-Cong , Zhong Ming , Ye Kai , You Jun , Xu Dong-Bo , Li Xin-Xiang , Xiong Zhi-Guo , Tao Kai-Xiong , Ding Ke-Feng , Zang Wei-Dong , Feng Yong , Pan Zhi-Zhong , Wu Ai-Wen , Huang Feng , Huang Ying , Wei Ye , Su Xiang-Qian , Chi Pan ,   LASRE trial investigators, He Guo-Dong , Yao Zhen-Dan , Xiao Yi , Lin Guo-Le , Gu Chao-Yang , He Xiao-Wen , Wang Ya-Nan , Li Qi-Ken , Guo Rui , Teng Da , Yang Yu-Gang , Qin Shao-Lan , Lin Jian-An , Hong Qing-Qi , Li Wen-Feng , Liang Lei , Hu Jun-Jie , Liu Xing-Hua , Li Jun , Zhang Hong 
Published: September 2022

Importance

The efficacy of laparoscopic vs open surgery for patients with low rectal cancer has not been established.

Objective

To compare the short-term efficacy of laparoscopic surgery vs open surgery for treatment of low rectal cancer.

Design, Setting, and Participants

This multicenter, noninferiority randomized clinical trial was conducted in 22 tertiary hospitals across China. Patients scheduled for curative-intent resection of low rectal cancer were randomized at a 2:1 ratio to undergo laparoscopic or open surgery. Between November 2013 and June 2018, 1070 patients were randomized to laparoscopic (n = 712) or open (n = 358) surgery. The planned follow-up was 5 years. Data analysis was performed from April 2021 to March 2022.

Interventions

Eligible patients were randomized to receive either laparoscopic or open surgery.

Main Outcomes and Measures

The short-term outcomes included pathologic outcomes, surgical outcomes, postoperative recovery, and 30-day postoperative complications and mortality.

Results

A total of 1039 patients (685 in laparoscopic and 354 in open surgery) were included in the modified intention-to-treat analysis (median [range] age, 57 [20-75] years; 620 men [59.7%]; clinical TNM stage II/III disease in 659 patients). The rate of complete mesorectal excision was 85.3% (521 of 685) in the laparoscopic group vs 85.8% (266 of 354) in the open group (difference, −0.5%; 95% CI, −5.1% to 4.5%; P = .78). The rate of negative circumferential and distal resection margins was 98.2% (673 of 685) vs 99.7% (353 of 354) (difference, −1.5%; 95% CI, −2.8% to 0.0%; P = .09) and 99.4% (681 of 685) vs 100% (354 of 354) (difference, −0.6%; 95% CI, −1.5% to 0.5%; P = .36), respectively. The median number of retrieved lymph nodes was 13.0 vs 12.0 (difference, 1.0; 95% CI, 0.1-1.9; P = .39). The laparoscopic group had a higher rate of sphincter preservation (491 of 685 [71.7%] vs 230 of 354 [65.0%]; difference, 6.7%; 95% CI, 0.8%-12.8%; P = .03) and shorter duration of hospitalization (8.0 vs 9.0 days; difference, −1.0; 95% CI, −1.7 to −0.3; P = .008). There was no significant difference in postoperative complications rate between the 2 groups (89 of 685 [13.0%] vs 61 of 354 [17.2%]; difference, −4.2%; 95% CI, −9.1% to −0.3%; P = .07). No patient died within 30 days.

Conclusions and Relevance

In this randomized clinical trial of patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons was shown to provide pathologic outcomes comparable to open surgery, with a higher sphincter preservation rate and favorable postoperative recovery.

Trial Registration

ClinicalTrials.gov Identifier: NCT01899547