Robotic vs. laparoscopic vs. open abdominoperineal resection for low rectal cancer: Short-term outcomes of a single-center prospective randomized controlled trial.

摘要

3603 Background: 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 robotic, laparoscopic and open abdominoperineal resection (APR) for low rectal cancer. Methods: From September 2013 to August 2016, 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 robotic procedures (RAP), laparoscopic procedures (LAP) or open surgery (OS) for APR in 1:1:1 ratio. The primary endpoint was postoperative complication rate. This study is registered with ClinicalTrials.gov (NCT01985698). Results: Totally 406 patients were randomly assigned. Actually, 135 finished RAP, 131 finished LAP, and 137 finished OS (including 4 convert from LAP to OS). RAP had significantly lower postoperative complication rate (11.1%) than both LAP (21.4%, P = 0.023) and OS (27.7%, P = 0.001). Also, RAP reduced intraoperative hemorrhage (median [interquartile range], 100 [90-110] ml) than LAP (130 [100-150] ml, P < 0.001) and OS (150 [120-260] ml, P < 0.001). And RAP promoted postoperative recovery, with shorter days to first flatus (1.0 [1.0-2.0] day) than LAP (2.0 [2.0-3.0] day, P < 0.001) and OS (3.0 [2.0-4.0] day, P < 0.001), shorter days to first automatic urination (2.0 [2.0-3.0] day) than LAP (3.0 [2.0-4.0] day, P < 0.001) and OS (3.0 [2.0-4.0] day, P < 0.001), and shorter days to discharge (5.0 [5.0-6.0] days) than LAP (6.0 [5.0-7.0] days, P < 0.001) and OS (6.0 [5.0-7.0] day, P = 0.005). There was no significant difference in open conversion rate, resection margin involvement (including circumferential resection margin), number of lymph node harvested and pathological tumor stage. Conclusions: Robotic APR was safer, and reproduce equivalent surgical quality of conventional laparoscopic and open surgery. Also, it provided less injury and faster functional recovery. Clinical trial information: NCT01985698.