Interim report: a randomized controlled trial comparing postoperative pain in single-incision laparoscopic cholecystectomy and conventional laparoscopic cholecystectomy.

ABSTRACT

INTRODUCTION: Single-incision laparoscopic cholecystectomy (SILC) is increasingly practiced, but there have been no well-powered randomized trials investigating the technique. This non-inferiority trial aims to compare SILC with conventional four-port laparoscopic cholecystectomy (LC) with postoperative pain as the primary endpoint. METHODS: We aim to randomize 100 patients into equal arms of SILC or LC. Exclusion criteria were (i) acute cholecystitis; (ii) an ASA score of 3 or above; (iii) bleeding disorders; or (iv) previous upper abdominal surgery. Patients and postoperative assessors were blinded to the procedure received. The site and severity of pain was compared based on the visual analogue scale at 4 hours, 24 hours and 14 days postoperatively; non-inferiority was assumed when the lower boundary of the 95% confidence interval of the difference was above -1, and superiority when P ≤ 0.05. RESULTS: We recruited 24 SILC and 26 LC patients. There were no conversions to open cholecystectomy or from SILC to LC. SILC was non-inferior for pain at umbilical sites at rest and at extra-umbilical sites at all times. At 24 hours postoperatively, SILC was associated with significantly less pain at extra-umbilical sites (rest P = 0.002; movement P = 0.004). There were no incidents of biliary injury or retained gallstones. Of the 24 SILC patients, 12.5% had postoperative complications (vomiting, mild fluid overload, wound infection) compared with 0% of LC patients (P = 0.110); all complications resolved with conservative management. Operating time, analgesic use, return to function, and overall satisfaction did not differ significantly between the two groups. CONCLUSION: SILC is associated with reduced pain and is feasible in routine surgical practice.