Department of Surgery, Division of General Surgery, McMaster University, Hamilton, ON, Canada.
Department of Surgery, Riverside Healthcare, Fort Frances, ON, Canada.
Int J Surg. 2018 Aug;56:141-147. doi: 10.1016/j.ijsu.2018.06.011. Epub 2018 Jun 12.
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.
This study is the first to evaluate the efficacy of simethicone in treating postoperative ileus symptoms in patients undergoing colorectal surgery.
A multicenter, double-blinded, placebo controlled randomized controlled trial.
This trial was conducted at two academic tertiary care centres in Ontario, Canada.
118 patients undergoing colorectal surgery.
Patients were randomized to receive either a five-day course of oral simethicone (n = 58) or a placebo (n = 60).
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.
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).
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.
术后肠麻痹是结直肠手术后一种尚未被充分了解的多因素临床结局，其会带来显著的临床挑战，并导致发病率增加、住院时间延长和医疗保健费用增加。迄今为止，只有少数药物干预措施可以缩短术后肠麻痹的持续时间。
本研究首次评估二甲硅油治疗结直肠手术后患者术后肠麻痹症状的疗效。
一项多中心、双盲、安慰剂对照的随机对照试验。
这项试验在加拿大安大略省的两个学术三级保健中心进行。
118 名接受结直肠手术的患者。
患者被随机分配接受为期 5 天的口服二甲硅油（n=58）或安慰剂（n=60）治疗。
主要结局是首次排气时间。次要结局包括首次排便时间、术后住院时间和术后疼痛。采用意向治疗进行统计分析。统计显著性水平设定为 p=0.05。
二甲硅油组首次排气时间中位数为 25.2 小时，对照组为 26.7 小时（P=0.98）。首次排便时间中位数（二甲硅油组为 41.1 小时，对照组为 42.9 小时，P=0.91）或中位住院时间（二甲硅油组为 4.5 天，对照组为 4.0 天，P=0.63）均无显著差异。
本研究未能显示结直肠手术后接受二甲硅油治疗的患者胃肠动力恢复存在差异。术后肠麻痹仍然是医疗保健系统的一个重大临床和经济负担，需要进一步研究以确定可靠和有效的治疗方法。
