Short-term outcomes of single-site robotic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective, randomized, double-blind trial

Abstract

Background: Randomized studies could not demonstrate significant outcome benefit after single-incision laparoscopic cholecystectomy compared to classic four-port laparoscopic cholecystectomy (CLC). The new robotic single-site platform might offer potential benefits on local inflammation and postoperative pain due to its technological advantages. This prospective randomized double-blind trial compared the short-term outcomes between single-incision robotic cholecystectomy (SIRC) and CLC.

Methods: Two groups of 30 eligible patients were randomized for SIRC or CLC. During the first postoperative week, patients and study monitors were blinded to the type of procedure performed by four dressing tapes applied on the abdomen. Pain was assessed at 6 h and on day 1, 7 and 30 after surgery, along with a 1-10 cosmetic score.

Results: No significant difference in postoperative pain occurred in the two groups at any time point nor for any of the abdominal sites. Nineteen (63 %) SIRC patients reported early postoperative pain in extra-umbilical sites. Intraoperative complications which might influence postoperative pain, such as minor bleeding and bile spillage, were similar in both groups and no conversions occurred. The cosmetic score 1 month postoperatively was higher for SIRC (p < 0.001). Two SIRC patients had wound infection, one of which developed an incisional hernia.

Conclusions: SIRC does not offer any significant reduction of postoperative pain compared to CLC. SIRC patients unaware of their type of operation still report pain in extra-umbilical sites like after CLC. The cosmetic advantage of SIRC should be balanced against an increased risk of incisional hernias and higher costs.

Trial registration number: ACTRN12614000119695 ( http://www.anzctr.org.au ).

Keywords: Laparoscopic cholecystectomy; Robotic; Single-site; Trial.