背景:腹腔镜治疗宫颈癌(LACC)的研究结果彻底改变了我们对这种疾病的最佳外科治疗方法的理解。在其发表之后,指南指出,根治性子宫切除术的标准和推荐方法是开腹手术。然而,LACC试验对根治性子宫切除术手术方式的真实世界变化的影响仍然难以捉摸.
目的:我们旨在研究根治性子宫切除术的趋势和途径,并评估LACC试验(2018年)前后的术后并发症发生率。
方法:国家外科质量改进计划注册用于检查2012-2022年间宫颈癌的根治性子宫切除术。我们排除了阴道根治性子宫切除术和单纯子宫切除术。主要结果指标是手术路线的趋势[微创手术(MIS)与开腹手术]和手术并发症发生率,按2018年LACC试验发表前后的时期分层(2012-2017年与2019-2022年)。次要结果指标是与不同手术途径特别相关的主要并发症。
结果:在纳入的3,611例患者中,2,080例(57.6%)接受了剖腹手术,1,531例(42.4%)接受了MIS根治性子宫切除术。从2012年到2017年,MIS方法显着增加(2012年MIS为45.6%,2017年MIS为75.3%,p<.001),2018年至2022年MIS大幅下降(2018年MIS为50.4%,2022年MIS为11.4%,p<.001)。在LACC试验之前的时期,轻微并发症的发生率较低[317(16.9%)与288(21.3%),p=.002]。LACC试验前后主要并发症发生率相似[139(7.4%)与78(5.8%),p=.26]。在LACC试验之前的时期,输血和浅表手术部位感染率较低[137(7.3%)与133(9.8%),p=.012和20(1.1%)与53(3.9%),分别为p<.001]。在MIS与MIS的比较中在整个研究期间开腹根治性子宫切除术,MIS组患者的轻微并发症发生率较低[190(12.4%)与472(22.7%),p<.001],两组的主要并发症发生率相似[MIS组100(6.5%)与剖腹手术组139例(6.7%),p=.89]。在具体的并发症分析中,MIS组的输血率和浅表手术部位感染率较低(2.4%vs.12.7%,和0.6%与3.4%,两种比较均p<.001),并且MIS组的深切口手术部位感染率较低(0.2%vs.0.7%,p=.048)。在多元逻辑回归分析中,根治性子宫切除术的途径与主要并发症的发生无关[aOR95%CI1.02(0.63-1.65)].
结论:虽然MIS根治性子宫切除术的比例在LACC试验后突然下降,术后主要并发症发生率无变化.此外,子宫切除术途径与主要的术后并发症无关.
BACKGROUND: The Laparoscopic Approach to Cervical Cancer (LACC) study results revolutionized our understanding of the best surgical management for this disease. Following its publication, guidelines state that the standard and recommended approach for radical hysterectomy is with an open abdominal approach. Nevertheless, the impact of the LACC trial on real-world changes in the surgical approach to radical hysterectomy remains elusive.
OBJECTIVE: We aimed to study the trends and routes of radical hysterectomies and to evaluate post-operative complication rates before and after the LACC trial (2018).
METHODS: The National Surgical Quality Improvement Program registry was used to examine radical hysterectomies performed for cervical cancer between 2012-2022. We excluded vaginal radical hysterectomies and simple hysterectomies. The primary outcome measures were the trends in route of surgery [minimally invasive surgery (MIS) vs. laparotomy] and surgical complications rate, stratified by periods before and after the publication of the LACC trial in 2018 (2012-2017 vs. 2019-2022). The secondary outcome measure was major complications associated specifically with the different routes of surgery.
RESULTS: Of the 3,611 patients included, 2,080 (57.6%) underwent laparotomy and 1,531 (42.4%) underwent MIS radical hysterectomy. There was a significant increase in the MIS approach from 2012 to 2017 (45.6% MIS in 2012 to 75.3% MIS in 2017, p<.001), and a significant decrease in MIS from 2018 to 2022 (50.4% MIS in 2018 to 11.4% MIS in 2022, p<.001). The rate of minor complications was lower in the period before the LACC trial [317 (16.9%) vs. 288 (21.3%), p=.002]. Major complications rate was similar before and after the LACC trial [139 (7.4%) vs. 78 (5.8%), p=.26]. The rates of blood transfusions and superficial surgical site infections were lower in the period before the LACC trial [137 (7.3%) vs. 133 (9.8%), p=.012 and 20 (1.1%) vs. 53 (3.9%), p<.001, respectively]. In a comparison of MIS vs. laparotomy radical hysterectomy during the entire study period, patients in the MIS group had lower rates of minor complications [190 (12.4%) vs. 472 (22.7%), p<.001] and the rate of major complications was similar in both groups [100 (6.5%) in the MIS group vs. 139 (6.7%) in the laparotomy group, p=.89]. In a specific complications analysis, the rates of blood transfusion and superficial surgical site infections were lower in the MIS groups (2.4% vs. 12.7%, and 0.6% vs. 3.4%, p<.001 for both comparisons) and the rate of deep incisional surgical site infections was lower in the MIS group (0.2% vs. 0.7%, p=.048). In a multiple logistic regression analysis, the route of radical hysterectomy was not independently associated with occurrence of major complications [aOR 95% CI 1.02 (0.63-1.65)].
CONCLUSIONS: While the proportion of MIS radical hysterectomy decreased abruptly following the LACC trial, there was no change in the rate of major post-operative complications. In addition, hysterectomy route was not associated with major post-operative complications.