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Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial

机译:腹腔镜阑尾切除术治疗术后术后静脉内抗生素是简单的阑尾炎吗? 一个预期的双盲随机对照试验

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Background: There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy. Methods: Following ethical approval, children (<= 16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann WhitneyUtest, Chi-square test, as appropriate, aP-value <= 0.05 was considered significant. Results: A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M,P= 0.8), median age (12.4 vs 12.2 years,P= 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours,P= 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx,P= 0.01 [relative risk for WI 7.9 (95% confidence interval: 1.0-62.4)]. There were no intra-abdominal abscess in either groups. Conclusions: This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.
机译:背景:在儿童中使用术后抗生素的术语有限的证据。我们的目标是进行预期的双盲随机对照试验,以在腹腔镜阑尾切除术后进行调查。方法:遵守伦理批准后,在一个机构招募了接受阑尾切除术的儿童(<= 16岁)。患者术中随机化接受2个术后静脉剂量的安慰剂或抗生素(ABX)。所有患者在麻醉诱导时接受了一剂ABX。初级结果是术后伤口感染(WI)的发生率,二次结果是腹部脓肿形成的发生率。数据报告为案例(%),中位数(范围),相对风险和使用Mann Whitneytest,Chi-Square测试进行分析,适当地,AP值<= 0.05被认为是显着的。结果:共有304名患者随机化。随后由于协议违规或招聘错误而被排除六十一;因此,最终分析中包含243个。一百二十二名患者接受安慰剂和121例静脉内ABX。性别之间没有差异(50f / 72 m vs 47f / 74 m,p = 0.8),中位年龄(12.4 vs 12.2岁,p = 0.5),并且在医院住院的术后长度(27.2 vs 25.6小时, p = 0.7)。术前血液结果也没有差异。总共发生9个WIS:8/122(6.6%)安慰剂与1/121(0.8%)ABX,P = 0.01 [Wi 7.9的相对风险(95%置信区间:1.0-62.4)]。两组中没有腹部脓肿。结论:这种前瞻性随机双盲随机对照试验揭示了通过给出2剂的静脉注射剂量的ABX,表明术后ABX在SA中有益。

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