Prospective Randomized Controlled Study to Compare the Outcome of Standard 4-Port Laparoscopic Cholecystectomy with Single-Incision Laparoscopic Cholecystectomy in Patients with Gallstone Disease

Abstract

Four-port laparoscopic cholecystectomy (LC) is the gold standard treatment for symptomatic gallbladder disease. To reduce the invasiveness of standard four-port laparoscopic cholecystectomy, single-incision laparoscopic cholecystectomy (SILC) has come about an attractive option for the performance of laparoscopic cholecystectomy. There have been no studies on SILC from Indian subcontinent. The present study was designed to compare the outcomes of SILC with the standard four-port LC in a prospective randomized controlled trial. All patients with symptomatic gallstone disease were evaluated between May 2012 and April 2014. Patients were randomized to either standard four-port laparoscopic cholecystectomy (LC group) or single-incision laparoscopic cholecystectomy (SILC group). Demographic profile, preoperative and intraoperative variables, postoperative complications, hospital stay, and pain scores were recorded. WHO-QOL BREF was used for quality of life analysis. Patients were followed up at regular intervals, and satisfaction scores were recorded. Statistical analysis was done using STATA 12 and p value < 0.05 was considered significant. Out of 94 patients, 90 received the intended treatment, and four cases in SILC group were converted to standard four-port cholecystectomy. The demographic profile and preoperative WHO-QOL BREF scores were comparable between the two groups. Severity of adhesions, successful dissection of Calot’s triangle, ergonomics, and overall level of difficulty were also comparable. Operation time was significantly higher in SILC group, but the learning curve was seen to be achieved after 30–35 cases. There was no significant difference in the incidence of immediate postoperative and chronic pain over a mean follow-up of 6 months except for pain score during normal activity in immediate postoperative period which was significantly higher in SILC group. Overall complication rate was significantly higher in SILC group, however the incidence of SSI was not found to be significant among the two groups. There was one case of transient bile leak and one case of intra-abdominal bleeding due to slippage of cystic artery clip. Postoperative quality of life outcomes were similar in the two groups. Although not significant, patients with SILC group had higher cosmetic score compared with the LC group. In conclusion, this study shows that SILC is a safe and feasible with a higher rate of complications but comparable cosmetic and QoL outcomes when compared with standard 4-port cholecystectomy.