Birchall Courtney L, Maines Jaimie L, Kunselman Allen R, Stetter Christy M, Pauli Jaimey M
Department of Obstetrics and Gynecology, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.
Attending Physician Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.
J Matern Fetal Neonatal Med. 2022 Dec;35(26):10253-10261. doi: 10.1080/14767058.2022.2113512. Epub 2022 Sep 30.
The primary objective of this study was to report surgical outcomes for cesarean delivery (CD) patients following the implementation of an Enhanced Recovery after Surgery (ERAS) pathway based on the ERAS Society recommendations. The primary outcome for which the study was powered was the length of stay (LOS).
This IRB-approved cohort study was conducted at a single tertiary-care labor and delivery unit and utilized a pre-post intervention design. Our ERAS for CD protocol was designed using the ERAS Society recommendations and implemented globally for every patient admitted to the labor and delivery unit including both scheduled and unscheduled cases. The study was designed to have at least 85% power to detect a 6-h difference in length of stay (LOS) between the pre-intervention and post-intervention cohorts, assuming a standard deviation of 18 h. A total of 339 records were included for data analysis, 170 in the pre-intervention cohort and 169 in the post-intervention cohort. To assess the difference between groups with respect to the primary outcome of LOS, linear regression was used with and without adjusting for covariates. Differences in dichotomous secondary outcomes were assessed using binary logistic regression. Differences in continuous secondary outcomes were assessed a two-sample -test or Wilcoxon rank sum test. Individual components of protocol adherence were compared using chi-square tests.
Mean LOS was 80.5 ± 22.9 h and 82.3 ± 28.0 h, pre- and post-intervention respectively. There was no difference in LOS between the 2 cohorts (difference of means = 1.8 h; 95% confidence interval (CI): (-3.7, 7.3); = .51). Cesarean procedure infection decreased from 11.8% pre-intervention to 5.3% post-intervention, corresponding to a 58% decrease in odds of cesarean procedure infection (odds ratio (OR)=0.42; 95% CI: (0.19, 0.96); = .04). Inpatient opioid use also significantly decreased in the post-intervention cohort with a median MME per 12 h-period of 5.1 (25 percentile = 2.2, 75 percentile = 7.8) pre-intervention and 3.3 (25 percentile = 1.0, 75 percentile = 7.6) post-intervention ( = .04).
The results of this study support the implementation of an ERAS for CD protocol based on ERAS Society recommendations as evidenced by the statistically significant decrease observed in both procedure-related infection rates and inpatient opioid use. We did not find a significant difference in LOS, which leaves room for further investigation into factors that impact LOS after CD.
本研究的主要目的是报告基于加速康复外科(ERAS)学会建议实施加速康复外科路径后剖宫产(CD)患者的手术结局。该研究的主要结局指标是住院时间(LOS)。
这项经机构审查委员会批准的队列研究在一家三级医疗的产科病房进行,采用干预前后设计。我们的剖宫产加速康复外科方案是根据ERAS学会的建议设计的,并在全球范围内应用于产科病房收治的每一位患者,包括计划内和计划外病例。该研究旨在至少有85%的把握度来检测干预前和干预后队列之间住院时间有6小时的差异,假设标准差为18小时。总共纳入339份记录进行数据分析,干预前队列170份,干预后队列169份。为评估两组在住院时间这一主要结局方面的差异,使用了线性回归,且有无调整协变量两种情况均进行了分析。二分类次要结局的差异采用二元逻辑回归进行评估。连续次要结局的差异采用两样本t检验或Wilcoxon秩和检验进行评估。方案依从性的各个组成部分采用卡方检验进行比较。
干预前和干预后平均住院时间分别为80.5±22.9小时和82.3±28.0小时。两组之间的住院时间无差异(均值差异=1.8小时;95%置信区间(CI):(-3.7,7.3);P=0.51)。剖宫产手术感染率从干预前的11.8%降至干预后的5.3%,相当于剖宫产手术感染几率降低了58%(比值比(OR)=0.42;95%CI:(0.19,0.96);P=0.04)。干预后队列中住院患者阿片类药物的使用也显著减少,干预前每12小时期间的平均吗啡毫克当量(MME)中位数为5.1(第25百分位数=2.2,第75百分位数=7.8),干预后为3.3(第25百分位数=1.0,第75百分位数=7.6)(P=0.04)。
本研究结果支持基于ERAS学会建议实施剖宫产加速康复外科方案,手术相关感染率和住院患者阿片类药物使用均有统计学意义的显著下降即为证明。我们未发现住院时间有显著差异,这为进一步研究影响剖宫产后住院时间的因素留出了空间。