Background: Statins have numerous potential benefits relevant to abdominal surgery and their use has been associated with a reduction in the systemic inflammatory response syndrome, wound infection and anastomotic leak following colorectal surgery. However, this clinical evidence is limited to retrospective studies. The aim of this study was to prospectively investigate whether perioperative statin therapy can decrease the incidence of complications following major colorectal surgery. Study Design: A prospective, double-blind, parallel-group randomised controlled trial was conducted at three tertiary hospitals in New Zealand between October 2011 and August 2013. Adult patients undergoing elective colorectal resection for any indication or reversal of Hartmann’s procedure were randomised with a 1:1 patient allocation ratio to receive either 40mg oral simvastatin or placebo once daily for 3 to 7 days preoperatively till 14 days postoperatively. The primary outcome was the overall incidence of complications for 30-days postoperatively. Secondary outcomes included the systemic and peritoneal cytokine response (IL-1?, IL-1?, IL-6, IL-8, IL-10, TNF?) on postoperative day 1.Results: 132 patients were included in the study (65 simvastatin, 67 placebo). There were no significant differences between the two groups at baseline with regards to patient, operation and disease characteristics. There were no significant differences between the two groups in the incidence, grade and type of postoperative complications (simvastatin: 44 [68%] versus placebo: 50 [75%], odds ratio 0.71 [95%CI 0.33 to 1.52], P=0.444). Plasma concentrations of IL-6, IL-8 and TNF?, and peritoneal concentrations of IL-6 and IL-8, were significantly lower in the simvastatin group postoperatively. Conclusions: Perioperative simvastatin therapy in major colorectal surgery attenuates the early pro-inflammatory response to surgery but there were no differences in postoperative complications.
Andrew G Hill
Counties Manukau Health