Single-port transumbilical laparoscopic cholecystectomy: A prospective randomised comparison of clinical results of 140 cases

INTRODUCTION: A novel single port access (SPA) cholecystectomy approach is described in this study. We have designed a randomised comparative study in order to elucidate any possible differences between the standard treatment and this novel technique. MATERIALS AND METHODS: Between July 2009 and March 2010, 140 adult patients with gallbladder pathologies were enrolled in this multicentre study. Two surgeons (RV and UB) randomised patients to either a standard laparoscopic (SL) approach group or to an SPA cholecystectomy group. Two types of trocars were used for this study: the TriPort™ and the SILS™ Port. Outcomes including blood loss, operative time, complications, length of stay and pain were recorded. RESULTS: There were 69 patients in the SPA group and 71 patients in the SL group. The mean age of the patients was 43.2 (17-77) for the SPA group and 42.6 (19-70) for the SL group. The mean operative time was 63.9 min in the SPA group and 58.4 min in the SL group. For one patient, the SPA procedure was converted to a standard laparoscopic technique and to open approach in the SL group. Complications occurred in eight patients: Five seromas (two in the SPA group) and three hernias (one in the SPA group).The mean hospital stay was 38.5 h in the SPA group and 24.1 h in the SL group. Pain was evaluated and was 2 in the SPA and 2.9 in the SL group, according to the visual analogue scale (VAS) after 24 h (P<0.001). The degree of satisfaction was higher in the SPA group (8.3 versus 6.7). Similar results were found for the aesthetic result (8.8 versus 7.5). (P<0.001). CONCLUSION: Single-port transumbilical laparoscopic cholecystectomy can be feasible and safe. When technical difficulties arise, early conversion to a standard laparoscopic technique is advised to avoid serious complications. The SPA approach can be undertaken without the expense of additional operative time and provides patients with minimal scarring. The cosmetic results and the degree of satisfaction appear to be significant for the SPA approach.