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

Abstract

Abstract 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).