Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA; Advocate Children's Hospital, Chicago, IL, USA.
University of Wisconsin-Madison, Madison, WI, USA.
J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25.
Use of prophylactic antibiotics after stented hypospadias repair is very common, but most research has not identified any clinical benefits of this practice. Only one study has found that postoperative prophylaxis reduces symptomatic urinary tract infections (UTIs). Data from the same trial suggested that prophylaxis may also reduce urethroplasty complications. No studies on this subject have been placebo-controlled.
We performed a randomized, double-blind, placebo-controlled study to evaluate the effect of postoperative prophylactic antibiotics on the incidence of infection or urethroplasty complications after stented repair of midshaft-to-distal hypospadias.
Boys were eligible for this multicenter trial if they had a primary, single-stage repair of mid-to-distal hypospadias with placement of an open-drainage urethral stent for an intended duration of 5-10 days. Participants were randomized in a double-blind fashion to receive oral trimethoprim-sulfamethoxazole or placebo twice daily for 10 days postoperatively. The primary outcome was a composite of symptomatic UTI, surgical site infection (SSI), and urethroplasty complications, including urethrocutaneous fistula, meatal stenosis, and dehiscence. Secondary outcomes included each component of the primary outcome as well as acute adverse drug reactions (ADRs) and C. difficile colitis.
Infection or urethroplasty complications occurred in 10 of 45 boys (22%) assigned to receive antibiotic prophylaxis as compared with 5 of 48 (10%) who received placebo (relative risk [RR], 2.1; 95% confidence interval [CI], 0.8 to 5.8; p = 0.16). There were no significant differences between groups in symptomatic UTIs, SSIs, or any urethroplasty complications. Mild ADRs occurred in 3 of 45 boys (7%) assigned to antibiotics as compared with 5 of 48 (10%) given placebo (RR, 0.6; 95% CI, 0.2 to 2.5; p = 0.72). There were no moderate-to-severe ADRs, and no patients developed C. difficile colitis.
In this placebo-controlled trial of 93 patients, prophylactic antibiotics were not found to reduce infection or urethroplasty complications after stented mid-to-distal hypospadias repair. The study did not reach its desired sample size and was therefore underpowered to independently support a conclusion that prophylaxis is not beneficial. However, the result is consistent with most prior research on this subject.
NCT02096159.
在带支架的尿道下裂修复术后使用预防性抗生素非常普遍，但大多数研究并未确定这种做法的任何临床益处。只有一项研究发现术后预防可降低有症状的尿路感染（UTI）。来自同一试验的数据表明，预防还可能减少尿道成形术并发症。尚无关于该主题的安慰剂对照研究。
我们进行了一项随机、双盲、安慰剂对照研究，以评估术后预防性抗生素对带支架修复中远端尿道下裂后感染或尿道成形术并发症的影响。
如果男孩接受了原发性一期修复中远端尿道下裂，放置开放式引流尿道支架，预期持续 5-10 天，则有资格参加这项多中心试验。参与者以双盲方式随机接受口服甲氧苄啶-磺胺甲恶唑或术后 10 天每天两次接受安慰剂。主要结局是症状性尿路感染、手术部位感染（SSI）和尿道成形术并发症的综合指标，包括尿道皮瘘、尿道口狭窄和裂开。次要结局包括主要结局的各个组成部分以及急性药物不良反应（ADR）和艰难梭菌结肠炎。
与接受安慰剂的 48 名男孩中的 5 名（10%）相比，接受抗生素预防的 45 名男孩中有 10 名（22%）发生感染或尿道成形术并发症（相对风险 [RR]，2.1；95%置信区间 [CI]，0.8 至 5.8；p=0.16）。两组之间在症状性 UTI、SSI 或任何尿道成形术并发症方面均无显著差异。与接受安慰剂的 48 名男孩中的 5 名（10%）相比，接受抗生素的 45 名男孩中有 3 名（7%）出现轻度 ADR（RR，0.6；95%CI，0.2 至 2.5；p=0.72）。没有中度至重度 ADR，也没有患者发生艰难梭菌结肠炎。
在这项对 93 名患者进行的安慰剂对照试验中，未发现预防性抗生素可降低带支架中远端尿道下裂修复术后的感染或尿道成形术并发症。该研究未达到预期的样本量，因此无法独立支持预防措施无益的结论。但是，结果与该主题的大多数先前研究一致。
NCT02096159
