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

Abstract

Abstract 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).