A randomized multicenter study of minilaparotomy cholecystectomy versus laparoscopic cholecystectomy with ultrasonic dissection in both groups.

ABSTRACT

OBJECTIVE: Ultrasonic dissection (UsD) has been used in laparoscopic cholecystectomy (LC), though it is not the golden standard technique. Applying UsD to cholecystectomy by minilaparotomy (MC) is less common and there are no prospective randomized trials comparing these two techniques. Therefore, we conducted the present study to investigate the use of the UsD in the MC versus the LC procedure. MATERIAL AND METHODS: Initially 104 patients with non-complicated symptomatic gallstone disease were randomized into MC (n = 53) or LC (n = 51) groups, both groups using UsD, over a period of 2 years (2013-2015). The study groups were similar in terms of age and American Society of Anesthesiologists (ASA) physical status score. RESULTS: The demographic variables and the surgical data were similar in the study groups. Similar low postoperative pain scores were reported in the two study groups during the first four hours after surgery. The incidence of nausea/vomiting was similar between the two study groups, 47% in the MC group versus 42% in the LC group. However, the patients in the MC group were treated more frequently with antiemetics, the incidence being 39% in the MC group versus 21% in the LC group (p = 0.02). The pain at rest at 24h after the surgery was similar in the two study groups, but the LC patients reported less pain at the normal activity, the mean of numerical rating scale (NRS) of 0-10 score being 3.9 in the MC group versus 2.9 in the LC group (p = 0.05), and the pain at the quick movement/coughing, the mean NRS being 4.9 in the MC group versus 3.2 in the LC group (p = 0.005). The length of sick leave was 17.4 days in the MC group and 14.4 days in the LC group (p = 0.05). CONCLUSION: Our results suggest that both MC and LC are feasible and safe options for mini-invasive cholecystectomy. A new finding with clinical relevance in the present work is a relatively similar short-term outcome in the MC and LC although the LC patients reported significantly lower pain score 24 hours postoperatively and a shorter convalescence.