Laparo-endoscopic single site cholecystectomy versus standard laparoscopic cholecystectomy: Results of a pilot randomized trial

BACKGROUND: In recent years, new devices providing multiple channels have made the performance of laparoscopic cholecystectomy through a single access site not only feasible but much easier. The potential benefits of laparoendoscopic single-site (LESS) cholecystectomy may include scarless surgery, reduced postoperative pain, reduced postoperative length of stay, and improved postoperative quality of life. There are no comparative data between LESS cholecystectomy and standard laparoscopic cholecystectomy (LC) available at present with which to quantify these benefits. METHODS: This study was a prospective, randomized, dual-institutional pilot trial comparing LESS cholecystectomy with standard LC. The primary end point was postoperative quality of life, measured as length of hospital stay, postoperative pain, cosmetic results, and SF-36 questionnaire scores. Secondary end points included operative time, conversion to standard LC, difficulty of exposure, difficulty of dissection, and complication rate. RESULTS: No significant differences in postoperative lengths of stay were found in the two groups. Postoperative pain evaluation using a visual analogue scale showed significantly better outcomes in the standard LC arm on the same day of surgery (P = .041). No differences in postoperative pain were found at the next visual analogue scale evaluation or in the postoperative administration of pain-relieving medications. Cosmetic satisfaction was significantly higher in the LESS group at 1-month follow-up (mean, 94.5 ± 9.4% vs 86 ± 22.3%; median, 100% vs 90%; P = .025). Among the 8 scales of the SF-36 assessing patients' physical and mental health, scores on the Role Emotional scale were significantly better in the LESS group (mean, 80.05 ± 29.42 vs 68.33 ± 25.31; median, 100 vs 66.67; P < .0001). CONCLUSIONS: In this pilot trial, LESS cholecystectomy resulted in similar lengths of stay and improved cosmetic results and SF-36 Role Emotional scores but performed less well on pain immediately after surgery. A larger multicenter trial is needed to confirm and further investigate these results.