Currently, robotic surgery for rectal cancer using da Vinci System is common. However, there is almost no clinical trial reported. This randomized controlled trial aims to compare the safety and efficacy of robot-assisted, laparoscopic and open abdominoperineal resection (APR) for low rectal cancer.
From 2013-09 to 2017-03, patients aged from 18 to 75 years, with low rectal cancer within 5 cm from anal verge, clinical T1 to T3, no distant metastases, were randomly assigned to receive either robot-assisted procedures (RAP), laparoscopic procedures (LAP) or open surgery (OS) for APR in 1:1:1 ratio. The primary endpoint was postoperative complication rate.
Totally 506 patients were enrolled in this study, randomly assigned to RAP (n = 169), LAP (n = 169), and OS (n = 168). Actually, 3 patients refused surgery, 173 finished RAP, 176 finished LAP, and 154 finished OS (including 4 convert from LAP to OS). The open conversion rate was 0 in RAP and 2.4% in LAP, with no significant difference (P = 0.123). In per-protocol analysis, no significant difference was observed in tumor location, size, differentiation and pathological TNM stage, among the three groups. RAP had significantly lower postoperative complication rate (10.4%) than both LAP (18.8%, P = 0.027) and OS (26.0%, P
Robot-assisted APR was safe, and reproduce equivalent surgical quality of conventional laparoscopic and open surgery. Also, it provided less injury and faster functional recovery.
Clinical trial identification
Legal entity responsible for the study
All authors have declared no conflicts of interest.