Randomized clinical trial of robot-assisted versus laparoscopic Nissen fundoplication.

BACKGROUND: Several studies have shown the safety and feasibility of robot-assisted antireflux surgery but comparative data are lacking.
METHODS: Fifty consecutive patients scheduled for laparoscopic antireflux surgery were randomized into two groups. Twenty-five patients underwent robot-assisted surgery and 25 standard laparoscopic fundoplication. All robot-assisted procedures were performed with the da Vinci Surgical System.
RESULTS: There were no significant differences in age, sex, body mass or preoperative reflux pattern between the groups. Operating times were significantly longer for robot-assisted than standard laparoscopic operations (mean total operating time 131.3 versus 91.1 min, P < 0.001; skin-to-skin time 78.0 versus 63.5 min, P = 0.001). There was no conversion to open surgery. Conversion to standard laparoscopy was necessary in one of 25 robot-assisted procedures. The length of hospital stay was similar in both groups. Robot-assisted surgery was associated with significantly higher mean total costs (euro 3157 versus euro 1527; P < 0.001). There were no significant differences in clinical, endoscopic and functional outcomes between groups. There was no procedure-related mortality.
CONCLUSION: Robot-assisted laparoscopic fundoplication is comparable to the standard laparoscopic procedure in terms of feasibility and outcome, but costs are higher owing to longer operating times and the use of more expensive instruments.

RCT Entities:   Population Interventions Outcomes