Randomized clinical trial of single-port, minilaparoscopic and conventional laparoscopic cholecystectomy.

BACKGROUND: This three-armed randomized clinical trial, with blinding of patients and outcome assessors, tested the hypothesis that single-port (SP) and/or minilaparoscopic (ML) cholecystectomy are superior to conventional laparoscopic (CL) cholecystectomy. METHODS: Patients eligible for elective laparoscopic cholecystectomy were randomized to SP, ML or CL procedures. The primary outcome was pain measured on a visual analogue scale twice daily during the blinded period. Secondary outcomes included duration of operation, technical performance score, complications, quality of life, cosmesis and patient satisfaction. Postoperative follow-up lasted 1 year. RESULTS: A total of 105 patients were randomized, 35 in each group. One conversion from a SP to a CL technique was necessary in a patient with chronic cholecystitis. Pain intensity was similar in the three groups, both during the blinded period (day 0 to 3; P = 0·865) and over the whole 7-day evaluation period (P = 0·911). The presence of clinically relevant between-group differences was ruled out (95 per cent confidence interval + 1·0 to - 0·5 for difference in pain scores between SP and CL groups, and - 0·8 to + 0·6 between ML and CL groups). Operating time was significantly longer for SP and ML than for CL cholecystectomy (P = 0·001). Postoperative complications included injury to the diaphragm (1), choledocholithiasis (1), wound infection (5) and hernia (1), all after SP cholecystectomy (P = 0·001). Twelve-month follow-up was complete in 99 patients (94·3 per cent). Cosmesis as rated by patients was significantly better at 6 months after SP and ML procedures (P = 0·043), but no difference was observed at 12 months (P = 0·229). CONCLUSION: SP and ML cholecystectomy had no advantage over the CL approach in terms of postoperative outcome. REGISTRATION NUMBER: DRKS00000302 (German Registry of Clinical Trials).

Single-port versus needlescopic versus conventional laparoscopic cholecystectomy: a comparative study.

INTRODUCTION: Single-port laparoscopic cholecystectomy (LC) has been recently introduced to achieve clinical benefits over standard LC. However, surgical outcomes of this operation have been poorly described compared with current techniques. The purpose of this study is to evaluate the surgical outcomes of single-port LC compared with needlescopic and conventional LC. METHODS: We reviewed the surgical outcomes of consecutive patients with symptomatic gallbladder stone disease who underwent single-port LC (31 cases), needlescopic LC (26 cases) and conventional LC (32 cases) from March 2009 to January 2010. Operation time, hospital stay, conversion, complications, and postoperative pain using visual analog scale were analyzed. In addition, patients were interviewed for overall satisfaction and cosmetic results. RESULTS: BMI in the single-port group was significantly lower than in the conventional group (26.0 ± 4.0 vs 30.8 ± 7.3 kg/m(2) , P=0.0017). Operation time in the single-port group was significantly longer than in the conventional group (65.1 ± 20.1 minutes vs 52.2 ± 19.6 minutes, P=0.012). There was one conversion in the single-port group. In nine cases in the single-port group (29%), a Kirschner wire or a suture retractor helped visualization. There was one complication in the single-port group (wound infection) and one in the needlescopic group (bile leak, requiring laparoscopy). Hospital stay, visual analog scale scores, and overall satisfaction did not vary among these groups. Greater cosmetic satisfaction was shown in the single-port group compared with the conventional group (P=0.039). CONCLUSION: Single-port LC is feasible and secure, with better cosmetic results than conventional LC. Further prospective randomized studies are still required to show its superiority over current LC techniques.