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. 2022 Sep 15;8(11):1607-1615.
doi: 10.1001/jamaoncol.2022.4079. Online ahead of print.

Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer: The LASRE Randomized Clinical Trial

Wei-Zhong Jiang  1 , Jian-Min Xu  2 , Jia-Di Xing  3 , Hui-Zhong Qiu  4 , Zi-Qiang Wang  5 , Liang Kang  6 , Hai-Jun Deng  7 , Wei-Ping Chen  8 , Qing-Tong Zhang  9 , Xiao-Hui Du  10 , Chun-Kang Yang  11 , Yin-Cong Guo  12 , Ming Zhong  13 , Kai Ye  14 , Jun You  15 , Dong-Bo Xu  16 , Xin-Xiang Li  17 , Zhi-Guo Xiong  18 , Kai-Xiong Tao  19 , Ke-Feng Ding  20 , Wei-Dong Zang  11 , Yong Feng  21 , Zhi-Zhong Pan  22 , Ai-Wen Wu  3 , Feng Huang  11 , Ying Huang  1 , Ye Wei  2 , Xiang-Qian Su  3 , Pan Chi  1 ; LASRE trial investigators
Collaborators, Affiliations

Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer: The LASRE Randomized Clinical Trial

Wei-Zhong Jiang et al. JAMA Oncol. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure.
Figure.. Flowchart of Patient Enrollment and Randomization
aData are not available for the number of patients screened for eligibility. bAbbreviation: mITT, modified intention to treat.
See this image and copyright information in PMC

Comment in

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