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美国食品和药物管理局发布子宫旋切术咨询公告后,子宫切除术方式的变化趋势。

Trends in Mode of Hysterectomy After the U.S. Food and Drug Administration Power Morcellation Advisory.

机构信息

Division of Minimally Invasive Gynecologic Surgery and the Department of Obstetrics and Gynecology Epidemiology Center, Brigham and Women's Hospital, Boston, Massachusetts.

出版信息

Obstet Gynecol. 2017 Jun;129(6):1014-1021. doi: 10.1097/AOG.0000000000002058.

Abstract

OBJECTIVE

To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines.

METHODS

This is a retrospective review of all patients who underwent a hysterectomy for benign indications, specifically for leiomyomas, at Brigham and Women's Hospital from 2013 to 2015. The rates of abdominal, vaginal, laparoscopic, and robotic-assisted laparoscopic hysterectomy as well as the perioperative outcomes were compared over the study period. Analysis was performed using multivariable linear, multinomial, and logistic regression. Regression models were adjusted for potential confounders.

RESULTS

From 2013 to 2015, 1,530 patients underwent a hysterectomy for benign indications and 639 patients underwent the procedure for the indication of uterine leiomyomas; there was a decrease in the number of hysterectomy cases in the later years. Focusing on the patients with leiomyomas alone, there was a 40-60% decreased odds of a minimally invasive procedure in 2014 or 2015 compared with 2013 [adjusted odds ratio (OR) 0.53 (0.29-0.97) in 2014 and adjusted OR 0.40 (0.22-0.74) in 2015, P=.003]. A 24% decrease in the supracervical approach to hysterectomy was also noted. Despite these trends, the majority of cases in each year were still performed in a minimally invasive fashion. The factor most strongly associated with undergoing a minimally invasive hysterectomy was having a fellowship-trained surgeon perform the procedure [adjusted OR 6.80 (3.65-12.7), P<.001]. There was no significant difference between the year of surgery and occurrence of intraoperative complications or reoperation.

CONCLUSION

Although key perioperative outcomes remained similar, the overall rate of minimally invasive surgery declined at our institution after the FDA's recommendations. With changing practice patterns and vigilance surrounding power morcellation, gynecologic surgeons may still offer patients minimally invasive procedures with all of the accompanying advantages.

摘要

目的

评估 2014 年美国食品和药物管理局(FDA)旋切术指南发布后良性子宫切除术手术方式的变化趋势。

方法

本研究为回顾性分析,纳入 2013 年至 2015 年在布莱根妇女医院因良性疾病(特定为子宫肌瘤)接受子宫切除术的所有患者。比较研究期间经腹、经阴道、腹腔镜和机器人辅助腹腔镜子宫切除术的比例以及围手术期结局。采用多变量线性、多项和逻辑回归分析。回归模型调整了潜在混杂因素。

结果

2013 年至 2015 年,1530 例患者因良性疾病行子宫切除术,639 例患者因子宫肌瘤行子宫切除术;近年子宫切除术例数减少。仅关注子宫肌瘤患者,与 2013 年相比,2014 年或 2015 年微创术式的可能性降低了 40%60%[2014 年校正比值比(OR)为 0.53(0.290.97),2015 年校正 OR 为 0.40(0.220.74),P=.003]。经宫颈子宫切除术的比例也下降了 24%。尽管存在这些趋势,但每年仍有多数患者接受微创术式。接受微创子宫切除术的最重要因素是术者接受过专科培训[校正 OR 6.80(3.6512.7),P<.001]。手术年份与术中并发症或再次手术之间无显著差异。

结论

尽管主要围手术期结局相似,但在我们医院,FDA 发布指南后,微创手术的总体比例下降。随着手术方式的改变以及对电力旋切术的警惕,妇科医生可能仍会为患者提供微创术式,并带来所有伴随的优势。

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