本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.2302

摘要内容如下：

重要性

腹股沟疝修补术在早产儿中很常见，并且与相当高的发病率相关。腹股沟疝是否应在新生儿重症监护室出院前或出院后进行修补尚有争议。

目的

评估早期与晚期手术修补治疗早产儿腹股沟疝的安全性。

设计、设置和参与者

2013年9月至2021年4月，在39家美国医院进行了一项多中心随机临床试验，包括在首次住院期间诊断为腹股沟疝的早产儿。2023年1月3日完成随访。

干预措施

在早期修补策略中，婴儿在新生儿重症监护室出院前接受腹股沟疝修补术。在晚期修补策略中，计划在新生儿重症监护室出院后和婴儿超过55周的月经后年龄时进行疝修补。

主要成果和措施

主要转归是在10个月观察期内发生任何预先指定的严重不良事件（由盲法裁决委员会确定）。次要结果包括10个月观察期内的住院总天数。

结果

在随机抽取的338名婴儿（早期修补组172名，晚期修补组166名）中，320名接受了手术修补（86%为男性；亚裔占2%，黑人占30%，西班牙裔占16%，白人占59%，种族和民族不详的分别占9%和4%；出生时的平均胎龄为26.6周[SD，2.8周]；登记时的平均出生后年龄为12周[SD，5周]）。在308名（91%）资料完整的婴儿（早期修复组159名，晚期修复组149名）中，早期修复组44名（28%）vs晚期修复组27名（18%）至少发生1次严重不良事件（风险差异，-7.9%[95%可信区间，-16.9%至0%]；晚期修复获益的贝叶斯后验概率为97%）。在10个月的观察期内，早期修复组的住院天数中位数为19.0天（IQR，9.8至35.0天），而晚期修复组的住院天数中位数为16.0天（IQR，7.0至38.0天）（晚期修复获益的后验概率为82%）。在预先指定的亚组分析中，胎龄小于28周的婴儿和支气管肺发育不良的婴儿中，晚期修复减少至少发生1例严重不良事件的婴儿数量的概率更高（每个亚组的获益概率为99%）。

结论和相关性

在患有腹股沟疝的早产儿中，晚期修补策略导致较少的婴儿发生至少1次严重不良事件。这些发现支持将腹股沟疝修补术推迟到新生儿重症监护室首次出院后进行。

试用注册

ClinicalTrials.gov标识符：NCT01678638。

英文原文如下：

Abstracts

Importance  Inguinal hernia repair in preterm infants is common and is associated with considerable morbidity. Whether the inguinal hernia should be repaired prior to or after discharge from the neonatal intensive care unit is controversial.

Objective  To evaluate the safety of early vs late surgical repair for preterm infants with an inguinal hernia.

Design, Setting, and Participants  A multicenter randomized clinical trial including preterm infants with inguinal hernia diagnosed during initial hospitalization was conducted between September 2013 and April 2021 at 39 US hospitals. Follow-up was completed on January 3, 2023.

Interventions  In the early repair strategy, infants underwent inguinal hernia repair before neonatal intensive care unit discharge. In the late repair strategy, hernia repair was planned after discharge from the neonatal intensive care unit and when the infants were older than 55 weeks' postmenstrual age.

Main Outcomes and Measures  The primary outcome was occurrence of any prespecified serious adverse event during the 10-month observation period (determined by a blinded adjudication committee). The secondary outcomes included the total number of days in the hospital during the 10-month observation period.

Results  Among the 338 randomized infants (172 in the early repair group and 166 in the late repair group), 320 underwent operative repair (86% were male; 2% were Asian, 30% were Black, 16% were Hispanic, 59% were White, and race and ethnicity were unknown in 9% and 4%, respectively; the mean gestational age at birth was 26.6 weeks [SD, 2.8 weeks]; the mean postnatal age at enrollment was 12 weeks [SD, 5 weeks]). Among 308 infants (91%) with complete data (159 in the early repair group and 149 in the late repair group), 44 (28%) in the early repair group vs 27 (18%) in the late repair group had at least 1 serious adverse event (risk difference, -7.9% [95% credible interval, -16.9% to 0%]; 97% bayesian posterior probability of benefit with late repair). The median number of days in the hospital during the 10-month observation period was 19.0 days (IQR, 9.8 to 35.0 days) in the early repair group vs 16.0 days (IQR, 7.0 to 38.0 days) in the late repair group (82% posterior probability of benefit with late repair). In the prespecified subgroup analyses, the probability that late repair reduced the number of infants with at least 1 serious adverse event was higher in infants with a gestational age younger than 28 weeks and in those with bronchopulmonary dysplasia (99% probability of benefit in each subgroup).

Conclusions and Relevance  Among preterm infants with inguinal hernia, the late repair strategy resulted in fewer infants having at least 1 serious adverse event. These findings support delaying inguinal hernia repair until after initial discharge from the neonatal intensive care unit.

Trial Registration  ClinicalTrials.gov Identifier: NCT01678638.

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