Objective: The objective of our study was to assess the oncological safety of uterine manipulators (UMs) in apparent early-stage (FIGO I-II 2009) endometrial cancer treated by minimally invasive surgery (MIS). Methods: Our single-center retrospective study includes patients who underwent endometrial cancer surgery for apparent early-stage disease by either laparoscopy or by robotic or laparoscopic-assisted vaginal hysterectomy from November 2012 to December 2020. Data on UMs, isolated tumor cells (ITCs), cytology, lymphovascular space invasion, free cancer cells in fallopian tubes, stage, histology and grade were collected. Primary and secondary outcomes were cancer recurrence and disease-specific death. Kaplan–Meier curves and multivariate logistic regression were used for statistical analysis. Results: A total of 930 women with early-stage endometrial cancer were included; 789 (84.8%) had hysterectomy with a uterine manipulator and 141 (15.2%) without. A total of 88% had endometrioid histology, 71.6% were grade 1 and 95.7% had stage I disease. A higher risk of recurrence was observed with the Hohl manipulator (HR: 2.83. 95% CI: 1.004–7.98p= 0.0492) on univariate analysis. On multivariate analysis, neither UM was associated with recurrence. With a mean follow-up of 48 months (range 3–118), no effect was seen on disease-specific death in either Hohl or V-Care (HR: 1.66. 95% CI: 0.48–5.70 and HR:1.29. 95% CI: 0.33–4.98). In high-grade histologies, UMs were strongly associated with recurrence (HR: 12.1. 95% CI: 1.52–96.6p= 0.019) and disease-specific death (HR: 10.2. 95% CI: 1.12–92.1p= 0.032). Conclusions: The use of UMs in MIS for endometrial cancer was associated with higher rates of recurrence without affecting disease-specific death, except in high-grade histologies.
目的:本研究旨在评估子宫操纵器在微创手术治疗临床早期(2009年FIGO I-II期)子宫内膜癌中的肿瘤学安全性。方法:本单中心回顾性研究纳入2012年11月至2020年12月期间,因临床早期子宫内膜癌接受腹腔镜、机器人辅助或腹腔镜辅助经阴道子宫切除术的患者。收集子宫操纵器使用情况、孤立肿瘤细胞、细胞学检查、淋巴血管间隙浸润、输卵管游离癌细胞、分期、组织学类型及分级等数据。主要和次要结局指标分别为癌症复发和疾病特异性死亡。采用Kaplan-Meier曲线和多因素逻辑回归进行统计分析。结果:共纳入930例早期子宫内膜癌患者,其中789例(84.8%)使用子宫操纵器行子宫切除术,141例(15.2%)未使用。88%为子宫内膜样组织学类型,71.6%为1级,95.7%为I期疾病。单因素分析显示Hohl操纵器与更高的复发风险相关(HR:2.83,95% CI:1.004-7.98,p=0.0492)。多因素分析中,两种子宫操纵器均未显示与复发相关。平均随访48个月(范围3-118个月),Hohl和V-Care操纵器对疾病特异性死亡均无显著影响(HR:1.66,95% CI:0.48-5.70;HR:1.29,95% CI:0.33-4.98)。在高分级组织学类型中,子宫操纵器使用与复发(HR:12.1,95% CI:1.52-96.6,p=0.019)及疾病特异性死亡(HR:10.2,95% CI:1.12-92.1,p=0.032)显著相关。结论:在子宫内膜癌微创手术中使用子宫操纵器与更高的复发率相关,但不影响疾病特异性死亡,高分级组织学类型除外。