RESUMEN
BACKGROUND: Transumbilical incision has been applied in single-incision laparoscopy. Evidence for the effect of transumbilical incision on postoperative pain compared with infraumbilical incision is still lacking. METHODS: A randomized controlled trial (RCT) was conducted in a university hospital. Patients who underwent conventional laparoscopic cholecystectomy were randomized to have transumbilical or infraumbilical incision. Postoperative pain was measured using visual analog score at 6, 24 h, and 7 days post operation. Secondary outcomes were analgesic usage, length of stay, superficial surgical site infection (SSI), wound numbness, and hypersensitivity. Risk ratio and mean difference (MD) along with their 95% confidence intervals (CIs) were estimated. Adjusted analysis was done, if clinical unbalanced characteristics presented. The study was registered at http://ClinicalTrial.gov (ID NCT02738710). RESULTS: A total of 102 patients were enrolled in which 51 patients were randomized to each interventional group. Postoperative pain was not significantly different between the groups with the MD of - 0.07 (95% CI - 0.47, 0.35). Paracetamol usage was significantly 1 tab (95% CI - 1.9, - 0.1) less after transumbilical incision, but this was not significant after adjusting for unbalanced characteristics. Superficial SSI rate was much higher in the transumbilical than the infraumbilical group, i.e., 16 versus 4%, but this was not significant (p = 0.070). Satisfaction scores at 3 months were not different between the groups, with the corresponding means of 8.9 [standard deviation (SD) 1.3] and 9.0 (SD 1.0). CONCLUSIONS: Transumbilical incision had non-significant different pain compared to infraumbilical incision. Most patients in both groups were satisfied with the operation at 3 months. A further large RCT is required for comparing SSI between the two incisions.