Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.
Obstet Gynecol. 2019 Apr;133(4):643-649. doi: 10.1097/AOG.0000000000003181.
To characterize long-term national trends in surgical approach for hysterectomy after the U.S. Food and Drug Administration (FDA) warning against power morcellation for laparoscopic specimen removal.
This was a descriptive study using data from the American College of Surgeons National Surgical Quality Improvement Program from 2012 to 2016. We identified hysterectomies using Current Procedural Terminology codes. We used an interrupted time-series analysis to evaluate abdominal and supracervical hysterectomy trends surrounding The Wall Street Journal article first reporting morcellation safety concerns and the FDA safety communication. We compared categorical and continuous variables using χ, t, and Wilcoxon rank sum tests.
We identified 179,950 hysterectomies; laparoscopy was the most common mode of hysterectomy in every quarter. Before The Wall Street Journal article, there was no significant change in proportion of abdominal hysterectomies (0.3% decrease/quarter, P=.14). After The Wall Street Journal article, use of abdominal hysterectomy increased 1.1% per quarter for two quarters through the FDA warning (P<.001), plateaued for three quarters until March 2015 (P=.65), then decreased by 0.8% per quarter through 2016 (P<.001). Supracervical hysterectomy volume continuously decreased after the FDA warning (1.0% decrease per quarter, P<.001) and after three quarters (0.7% decrease per quarter, P=.01), then plateaued from April 2015 through 2016 (0.05% decrease per quarter, P=.40). Mode of supracervical hysterectomy was unchanged from 2012 to 2013 (P=.43), followed by two quarters of significant increase in proportion of supracervical abdominal hysterectomies (11.7%/quarter, P<.001). This change in mode of supracervical hysterectomy then plateaued through 2016 (P=.06).
Despite early studies suggesting that minimally invasive hysterectomy decreased in response to safety concerns regarding power morcellation, we found that this effect reversed 1 year after the FDA safety communication. However, there was a sustained decline in supracervical hysterectomy, and the remaining supracervical hysterectomies were more likely to be performed using laparotomy.
在美国食品和药物管理局(FDA)警告禁止使用电动旋切术进行腹腔镜标本切除后,描述长期的全美子宫切除术手术方式变化趋势。
本研究采用了美国外科医师学会国家手术质量改进计划 2012 年至 2016 年的数据,采用描述性研究方法。我们使用当前操作术语代码识别子宫切除术。我们使用中断时间序列分析评估《华尔街日报》首次报道旋切安全性问题和 FDA 安全通讯前后腹式和经宫颈子宫切除术的趋势。我们使用卡方检验、t 检验和 Wilcoxon 秩和检验比较了分类变量和连续变量。
我们共确定了 179950 例子宫切除术;腹腔镜是每个季度最常见的子宫切除术方式。在《华尔街日报》文章发表之前,腹式子宫切除术的比例没有明显变化(每季度减少 0.3%,P=.14)。在《华尔街日报》文章发表后,在 FDA 警告前两个季度,腹式子宫切除术的使用率每季度增加 1.1%(P<.001),在 2015 年 3 月达到峰值(P=.65),然后在 2016 年每季度减少 0.8%(P<.001)。在 FDA 警告后,经宫颈子宫切除术的数量持续减少(每季度减少 1.0%,P<.001),在警告后三个季度(每季度减少 0.7%,P=.01),然后在 2015 年 4 月至 2016 年期间达到平台期(每季度减少 0.05%,P=.40)。2012 年至 2013 年,经宫颈子宫切除术的方式没有变化(P=.43),随后的两个季度经宫颈腹式子宫切除术的比例显著增加(每季度增加 11.7%,P<.001)。经宫颈子宫切除术的这种方式变化随后在 2016 年达到平台期(P=.06)。
尽管早期研究表明,由于对电动旋切术安全性的担忧,微创子宫切除术减少,但我们发现,在 FDA 安全通讯发布一年后,这种影响出现了逆转。然而,经宫颈子宫切除术的数量持续下降,剩余的经宫颈子宫切除术更有可能通过剖腹手术进行。