Boonying Siribumrungwong1,2, Trirat Chunsirisub1, Palin Limpavitayaporn1, Assanee Tongyoo1, Ekkapak Sriussadaporn1, Chatchai Mingmalairak1, Weerayut Thowprasert1, Ammarin Thakkinstian3. 1. Department of Surgery, Faculty of Medicine, Thammasat University Hospital, Thammasat University, Pathum Thani, Thailand. 2. Center of Excellence in Applied Epidemiology, Faculty of Medicine, Thammasat University Hospital, Thammasat University, Pathum Thani, Thailand. 3. Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Rama VI road, Rachatevi, Bangkok, 10400, Thailand. Ammarin.tha@mahidol.ac.th.
Abstract
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.
RCT Entities:
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.