Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy: a randomized controlled trial.
SCARLESS Study Group None., Ahmed I., Cook JA., Duncan A., Krukowski ZH., Malik M., MacLennan G., McCormack K.
BACKGROUND AND OBJECTIVE: The aim of this study was to compare the effectiveness of single port/incision laparoscopic surgery (SPILS) with standard three-port laparoscopic surgery for appendicectomy in adults. Feasibility data was collected to evaluate generalizability to other single-port techniques such as cholecystectomy. METHODS: This was a single-center, randomized controlled trial. Participants were randomized to receive either SPILS or standard three-port laparoscopic appendicectomy. The primary patient-reported outcomes were body image and cosmesis at 6 weeks. The primary clinical outcome was pain at 1-7 days. Secondary outcomes included duration of operation, conversion rates, complication rates, use of analgesia, hospital re-admission rates, re-operation rates, and time to return to normal activities. RESULTS: Seventy-nine patients were randomized. Sixty-seven completed the day 1-7 diary and 53 completed the 6-week follow-up. SPILS patients answered significantly more favorably to the items in the body image scale [mean (SD) 5.6 (1.0) vs. 7.0 (3.3); -1.4 (95 % CI -2.8 to 1.5; p = 0.03)] and the cosmetic scale [18.9 (4.1) vs. 15.3 (5.8); 3.6 (95 % CI 0.7-6.5; p = 0.016)] compared with patients in the Standard group. The duration of operation was shorter for SPILS, and patients required less morphine in recovery; however, there were no statistically significant differences in other outcomes. CONCLUSIONS: Patient-reported body image and cosmesis outcomes were better, and surgical outcomes were similar following SPILS. However, the SPILS procedure is more technically demanding and may not be achievable or necessary in routine clinical care. Further assessment of the findings is needed through larger multicenter studies.