腹腔镜子宫切除术的途径、资源利用和结果：电切环（Power Morcellation）警示后的变化。

Laparoscopic Hysterectomy Route, Resource Use, and Outcomes: Change After Power Morcellation Warning.

机构信息

Departments of Obstetrics, Gynecology and Reproductive Sciences and Internal Medicine, Yale School of Medicine, the Department of Biostatistics, Yale School of Public Health, the Yale Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center, and the Yale School of Medicine, New Haven, Connecticut; CooperSurgical Inc., Trumbull, Connecticut; and the Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, New York.

出版信息

Obstet Gynecol. 2019 Aug;134(2):227-238. doi: 10.1097/AOG.0000000000003375.

DOI:10.1097/AOG.0000000000003375

PMID:31348209

Abstract

OBJECTIVE

To examine changes in utilization of different types of laparoscopic hysterectomy, as well as their associated resource use and surgical outcomes, after the U.S. Food and Drug Administration (FDA) safety statement in April 2014 regarding power morcellation.

METHODS

We retrospectively analyzed data from the 2012-2016 American College of Surgeons National Surgical Quality Improvement Program and identified 145,746 women undergoing hysterectomy for benign indications. We measured use of laparoscopic supracervical hysterectomy compared to total laparoscopic hysterectomy (including laparoscopic-assisted vaginal hysterectomy) in these patients, as well as operative time, surgical setting (inpatient vs outpatient), length of stay, and 30-day surgical outcomes (wound complication, medical complication, reoperation, and readmission). We used an interrupted time series analysis to examine the association between FDA warning and changes in utilization and outcomes of laparoscopic hysterectomy.

RESULTS

After adjusting for patient characteristics and background trends in practice, use of laparoscopic supracervical hysterectomy was significantly lower in the postwarning than prewarning period (odds ratio [OR]=0.49, 95% CI 0.45-0.53), whereas use of total laparoscopic hysterectomy was not affected (OR 1.01, 95% CI 0.96-1.06). Overall, after an initial reduction, use of laparoscopic hysterectomy (laparoscopic supracervical hysterectomy and total laparoscopic hysterectomy combined) increased over time in the postwarning period (adjusted OR of utilization for each calendar quarter elapsed=1.03, 95% CI 1.02-1.03). After the FDA warning, operative time for laparoscopic supracervical hysterectomy increased by 11.45 minutes (95% CI 6.22-16.69), whereas the decreasing trend in the likelihood of inpatient stay for total laparoscopic hysterectomy was attenuated (OR for each calendar quarter elapsed=0.92 in prewarning period, 95% CI 0.91-0.93; and 0.97 in postwarning period, 95% CI 0.97-0.98). There was no significant change in 30-day surgical outcomes after the FDA warning.

CONCLUSION

Rates of laparoscopic supracervical hysterectomy fell in association with power morcellation safety warnings, whereas rates of other laparoscopic hysterectomies continued to rise. There was no change in patient outcomes among laparoscopic hysterectomies.

摘要

目的

检查美国食品和药物管理局（FDA）在 2014 年 4 月发布关于电动切割的安全性声明后，不同类型腹腔镜子宫切除术的使用情况以及相关资源使用和手术结果的变化。

方法

我们回顾性分析了 2012-2016 年美国外科医师学会国家手术质量改进计划的数据，并确定了 145746 名因良性指征接受子宫切除术的女性。我们测量了这些患者中腹腔镜子宫次全切除术与全腹腔镜子宫切除术（包括腹腔镜辅助阴道子宫切除术）的使用情况，以及手术时间、手术环境（住院或门诊）、住院时间和 30 天手术结果（伤口并发症、医疗并发症、再次手术和再次入院）。我们使用中断时间序列分析来检查 FDA 警告与腹腔镜子宫切除术使用情况和结果变化之间的关联。

结果

在调整了患者特征和实践中背景趋势后，警告后腹腔镜子宫次全切除术的使用率明显低于警告前（比值比[OR] = 0.49，95%置信区间 0.45-0.53），而全腹腔镜子宫切除术的使用率没有受到影响（OR = 1.01，95%置信区间 0.96-1.06）。总体而言，在警告后期间，腹腔镜子宫切除术（腹腔镜子宫次全切除术和全腹腔镜子宫切除术的联合）的使用率最初下降后呈上升趋势（每个日历季度流逝的使用率调整比值比= 1.03，95%置信区间 1.02-1.03）。在 FDA 警告后，腹腔镜子宫次全切除术的手术时间增加了 11.45 分钟（95%置信区间 6.22-16.69），而全腹腔镜子宫切除术住院时间减少的趋势减弱（每个日历季度流逝的比值比在警告前期间为 0.92（95%置信区间 0.91-0.93）；而在警告后期间为 0.97（95%置信区间 0.97-0.98））。FDA 警告后，30 天手术结果无明显变化。