[Efficacy comparison between robot-assisted and laparoscopic surgery for mid-low rectal cancer: a prospective randomized controlled trial].

Objective: To compare the short- and long-term outcomes of robot-assisted and laparoscopic radical resection for mid-low rectal cancer. Methods: A prospective randomized controlled trial was conducted. A total of 130 patients with mid-low rectal cancer (inclusion criteria: age > 18 or ≤80 years old; pathological diagnosis of rectal adenocarcinoma by colonoscopy; distance from tumor to the anal verge ≤12 cm; no distant metastasis; cT1-3N0-1 or ycT1-3 after neoadjuvant radiotherapy and chemotherapy; suitable for laparoscopic and robotic surgery) at the Department of Colorectal Surgery of the First Affiliated Hospital of Nanchang University from October 2016 to September 2018 were prospectively enrolled. According to computer-generated random number method, patients were randomly divided into the robot group (n=66) and laparoscopy group (n=64), and underwent robot-assisted surgery or laparoscopic surgery respectively. Clinicopathological data of all the patients were collected and analyzed. The demographic parameters, short- and long-term outcomes were compared between two groups. Results: One patient in robot group whose postoperative sample was diagnosed as rectal adenoma by pathology was excluded. There were no statistically significant differences in age, sex, BMI, ASA classification, distance from tumor to the anal verge, serum CEA level, CA199 level between two groups (all P>0.05). Operations were successfully performed in all the patients without conversion to open operation. Robotic surgery was found to be associated with less intraoperative blood loss than laparoscopic surgery [(73.4±49.7) ml vs. (119.1±65.7) ml, t=-4.461, P<0.001], while there were no statistically significant differences in surgical procedures, operation time, time to first flatus, time to first liquid intake, time to removal of catheter or postoperative hospital stay between two groups (all P>0.05). Besides, there was no significant difference in the morbidity of postoperative complication between two groups [10.8% (7/65) vs. 12.5 (8/64), χ(2)=4.342, P=0.720]. The median number of harvested lymph node in the robot group and the laparoscopy group was 15.7±6.2 and 13.8±6.1 (t=1.724, P=0.087). There were no significant differences between two groups in tumor sample length, distance between proximal and distal resection margin, integrity grade of TME specimen, number of positive lymph nodes, postoperative pathological stage and tumor differentiation (all P>0.05). The distal resection margin of samples in two groups was all negative. One case in the robot group was found to have positive circumferential resection margin. The median follow up was 24 (9 to 31) months. In the robot group and the laparoscopy group, the 2-year overall survival rate was 95.4% and 90.6% respectively; the 2-year disease-free survival rate was 90.8% and 85.9% respectively, whose differences were not significant (both P>0.05). Conclusion: Robot-assisted radical resection for mid-low rectal cancer can achieve similar short-term and long-term outcomes of laparoscopic resection, while robot-assisted surgery can decrease blood loss during operation, leading to more precise practice in minimally invasive surgery.