OBJECTIVE: 

To estimate trends in use of laparoscopic power morcellators in women undergoing minimally invasive hysterectomy and to examine use of containment systems in these patients in relation to safety guidance from the U.S. Food and Drug Administration (FDA).

METHODS: 

We examined data that were recorded in the Premier Healthcare Database from patients who underwent laparoscopic supracervical hysterectomy from 2010 to 2018. Patients were stratified based on use of laparoscopic power morcellators. The cohort was further stratified as either pre–FDA guidance (2010 quarter 1–2014 quarter 1) or post–FDA guidance (2014 quarter 2–2018 quarter 2). Interrupted time series analyses were performed to determine the effect of FDA guidance on the use of laparoscopic power morcellators and containment bags.

RESULTS: 

Among 67,115 patients, laparoscopic power morcellator use decreased from 66.7% in 2013 quarter 4 to 13.3% by 2018 quarter 2. The likelihood of laparoscopic power morcellator use decreased by 9.5% for each quarter elapsed in the post–FDA warning period (risk ratio [RR] 0.91, 95% CI 0.90–0.91). Containment bag use rose from 5.2% in 2013 quarter 4 to 15.2% by 2018 quarter 2. The likelihood of containment bag use increased by 3% for each quarter elapsed in the post–FDA warning period (RR 1.03, 95% CI 1.02–1.05). Among women who had laparoscopic power morcellator use, uterine cancers or sarcomas were identified in 54 (0.17%) before the FDA guidance compared with seven (0.12%) after the guidance (P=.45). Containment bags were used in 11.1% of women with uterine cancers or sarcomas before the FDA guidance compared with 14.3% after the guidance (P=.12). The perioperative complication rate was 3.3% among women who had laparoscopic power morcellator use without a containment bag compared with 4.5% (P=.001) in those with a containment bag (aRR 1.35, 95% CI 1.12–1.64).

CONCLUSION: 

Use of laparoscopic power morcellators has decreased over time. Containment bag use increased after the FDA's 2014 guidance; however, most procedures employing laparoscopic power morcellators are still performed without a containment bag.

中文翻译：

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接受腹腔镜电动分碎术子宫切除术的女性使用密封袋

客观的： 

评估在接受微创子宫切除术的女性中使用腹腔镜电动粉碎器的趋势，并根据美国食品和药物管理局 (FDA) 的安全指南检查这些患者使用围堵系统的情况。

方法： 

我们检查了 2010 年至 2018 年接受腹腔镜宫颈上子宫切除术的患者记录在 Premier Healthcare 数据库中的数据。根据腹腔镜电动粉碎器的使用对患者进行分层。该队列进一步分层为 FDA 前指导（2010 年第一季度至 2014 年第一季度）或 FDA 后指导（2014 年第二季度至 2018 年第二季度）。进行了间断时间序列分析以确定 FDA 指南对使用腹腔镜电动粉碎器和密封袋的影响。

结果： 

在 67,115 名患者中，腹腔镜电动粉碎器的使用率从 2013 年第 4 季度的 66.7% 下降到 2018 年第 2 季度的 13.3%。在 FDA 后警告期（风险比 [ RR] 0.91, 95% CI 0.90–0.91)。密封袋的使用率从 2013 年第 4 季度的 5.2% 上升到 2018 年第 2 季度的 15.2%。在 FDA 警告期后的每个季度，密封袋使用的可能性增加 3%（RR 1.03，95% CI 1.02–1.05） ). 在使用腹腔镜电动粉碎器的女性中，FDA 指导前有 54 名 (0.17%) 患子宫癌或肉瘤，而指导后有 7 名 (0.12%)（P=.45）。在 FDA 指导之前，11.1% 的患有子宫癌或肉瘤的女性使用了密封袋，而在指导之后这一比例为 14.3%（P =.12）。在没有密封袋的情况下使用腹腔镜电动粉碎器的女性围手术期并发症发生率为 3.3%，而使用密封袋的女性围手术期并发症发生率为 4.5% ( P =.001) (aRR 1.35, 95% CI 1.12–1.64)。

结论： 

随着时间的推移，腹腔镜电动粉碎器的使用有所减少。在 FDA 2014 年指南发布后，密封袋的使用有所增加；然而，大多数使用腹腔镜动力粉碎器的手术仍然在没有密封袋的情况下进行。