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

Abstract

3516 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.