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临床试验/NCT05261165
NCT05261165已完成不适用

Effect of a Uterine Manipulator on the Incidence of Lymphovascular Propagation (LVSI) in Treatment of Endometrial Cancer

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
LVSI and intrauterine manipulator

研究概览

简要总结

We retrospectively analyzed data and compared the impact of intrauterine manipulators on incidence of LVSI in endometrial cancer patients treated at our department.

详细描述

Endometrial cancers are among the epithelial malignancies of the lining in the uterine cavity. Standard treatment is surgical, which includes a hysterectomy. The invasion of carcinoma into the lymphovascular space (LVSI - lymphovascular space invasion) is considered a risk factor for the course of the disease Based on the recommended procedures of ESGO-ESTRO-ESP (2020) in the management of endometrial cancer, in the event of significant LVSI positivity, the female patients are included in the upper-medium risk group. A confirmation of LVSI in the preparation is of diagnostic, therapeutic and theoretical importance. During endoscopy approach, we use two types of uterine manipulators, namely the Koh-RUMI manipulator (Cooper Surgical) and the Hegar dilatator along with the McCartney tube (LiNA Medical). We analyzed data and compared the impact of intrauterine manipulators on the incidence of LVSI. In addition, we analyzed tumor grading, invasion and primary histology obtaining methods - curettage or hysteroscopy in correlation to incidence of LVSI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • endometrioid endometrial cancer,
  • planned primary surgical treatment - hysterectomy,
  • medical condition enabling anesthesia and surgery,
  • pre-surgical clinically-determined affecting of the uterine according to MRI or ultrasound - cT1a or cT1b

排除标准

  • non-endometrioid type of tumor in definitive histology,
  • stage 2 of a disease and higher,
  • previous chemo or radiotherapy,
  • inability to adequately complete the surgery,
  • uterine perforation during surgery

结局指标

主要结局

LVSI and intrauterine manipulator

时间窗: oct. 2015 - jan. 2021

Finding of the difference in the incidence of LVSI in female patients with and without an intrauterine manipulator

次要结局

  • LVSI and type of intrauterine manipulator(oct. 2015 - jan. 2021)

研究者

发起方
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Boris Hudec, MD

Mr.

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

研究点 (1)

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