Randomized clinical study for assessment of incision characteristics and pain associated with LESS versus laparoscopic cholecystectomy.

Madureira, Fernando Athayde Veloso; Manso, José Eduardo Ferreira; Madureira Fo, Delta; Iglesias, Antonio Carlos Garrido

BACKGROUND Laparoendoscopic single-site surgery (LESS) has emerged as a technique that uses a natural scar, the umbilicus, within which a multiple-entry portal is placed into a 3.0-4.0-cm single incision to perform operations. The objective of this study was to compare incision size, wound complications, and postoperative pain of LESS compared with those of laparoscopic cholecystectomy (LC). METHODS A prospective randomized controlled study was conducted between January and June 2011 at two university hospitals in Rio de Janeiro, Brazil. Fifty-seven patients were randomly assigned to undergo laparoscopic or LESS cholecystectomy. Skin and aponeurosis wound sizes were recorded. A 10-point visual analog scale (VAS) was used to assess pain at postoperative hours 3 and 24. Healing and wound complications were assessed at follow-up. RESULTS A total of 57 patients, 53 women and 4 men with a mean age of 48.7 years, were randomly assigned to undergo LESS (n = 28) or LC (n = 29). The mean length of the umbilical skin incision was 4.0 cm (range = 2.1-5.8) in LESS and 2.7 cm (1.5-5.1) in LC (p < .0001). The mean internal aponeurosis diameter was 3.5 cm (2.0-5.5) in LESS and 2.3 cm (1.2-3.5) in LC (p < .0001). The mean operative time was 60.3 min (32-128) for LESS and 51.3 min (25-120) for LC (p = 0.11). Gallbladder perforation at detachment occurred in 15.69 % of the LESS cases and in 5.88 % of the LC cases (p = 0.028). The mean VAS score for pain at hour 3 was 2.0 points (0-7) for the LESS group and 4.0 (0-10) for the LC group (p = 0.07), and at postoperative hour 24 it was 0.3 points (0-6) for LESS and 2.3 (0-10) for LC (p = 0.03). There were no significant differences in wound complications. Incisional hernias were not found in either group. CONCLUSIONS The LESS single-port (SP) operations demand a bigger incision than LC surgery. However, there were no differences in healing, wound infections, and hernia development. We found a tendency of less postoperative pain associated with LESS/SP than with LC.