Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy

Background: Conventional laparoscopy with three or more ports remains the 'gold standard' for cholecystectomy, but a laparoendoscopic single-site (LESS) approach is emerging, designed to decrease parietal trauma and improve cosmesis. This study compared conventional laparoscopic (CL) with LESS cholecystectomy, with short-term clinical results as the main outcomes. Methods: A randomized trial of CL and LESS cholecystectomies involving 150 patients was undertaken. Follow-up was for 1 month after surgery. The primary endpoint was body image results evaluated by means of validated scales. Secondary endpoints were: postoperative pain measured on a visual analogue scale, analgesia requirement, morbidity, quality of life (QoL) measured with Short Form 12, duration of operation, hospital stay, time to return to work and cost analysis. Results: Operating times and complications were similar in the two groups. Two LESS procedures (3 per cent) were converted to two-port laparoscopy owing to difficulties with exposure, and one CL operation was achieved through a single port because extensive fibrous peritoneal adhesions prevented placement of other ports. There were three and four port-site seroma/haematomas in the LESS and CL groups respectively. Better pain profiles and lower analgesia requirements were recorded in the LESS group (P < 0.001). QoL, body image and scar scale results were also better (P < 0.001). Operative costs were higher for LESS procedures (P < 0.001), although median time to return to work was shorter (P = 0.003). Conclusion: LESS is an alternative to CL cholecystectomy associated with better cosmesis, body image, QoL and an improved postoperative pain profile. Registration number: NCT00904865 (http://www.clinicaltrials.gov).