The effect of simethicone on postoperative ileus in patients undergoing colorectal surgery (SPOT), a randomized controlled trial
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BACKGROUND: Postoperative ileus is a poorly understood multifactorial outcome following colorectal surgery that presents significant clinical challenges and contributes to increased morbidity, length of stay, and healthcare cost. To date, there are few pharmacological interventions that shorten the duration of postoperative ileus. OBJECTIVE: This study is the first to evaluate the efficacy of simethicone in treating postoperative ileus symptoms in patients undergoing colorectal surgery. DESIGN: A multicenter, double-blinded, placebo controlled randomized controlled trial. SETTINGS: This trial was conducted at two academic tertiary care centres in Ontario, Canada. PARTICIPANTS: 118 patients undergoing colorectal surgery. INTERVENTIONS: Patients were randomized to receive either a five-day course of oral simethicone (n = 58) or a placebo (n = 60). MAIN OUTCOME MEASURES: The primary outcome was time to first passage of flatus. Secondary outcomes included time to first bowel movement, postoperative length of stay, and postoperative pain. Statistical analyses were performed on an intention-to-treat basis. Statistical significance set at p = 0.05. RESULTS: The median time to first passage of flatus in simethicone arm was 25.2 h and 26.7 h in controls (P = 0.98). There were no significant differences in the median time to first bowel movement (simethicone = 41.1 h vs. control = 42.9 h, P = 0.91) or median length of hospital stay (simethicone = 4.5 days vs. control = 4.0 days, P = 0.63). CONCLUSIONS: This study failed to show a difference in return of gastrointestinal motility in patients receiving simethicone following colorectal surgery. Postoperative ileus remains a significant clinical and economic burden to the healthcare system and further research is needed to identify a reliable and effective method of treatment.