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NCT Number: NCT05261165

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hysterectomy

Procedure

Hysterectomy as primary surgical treatment of endometrial cancer. Abdominal laparotomy approach was performed without intrauterine manipulator (NonManip). Endoscopic - total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy or robotic hysterectomy was performed with use of intrauterine manipulator (Manip). It was Hegar dilatator (ManipHe) or Koh-Rumi device (ManipKoRu).

Primary outcomes

  1. LVSI and intrauterine manipulator

    Time frame: oct. 2015 - jan. 2021

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

Secondary outcomes

  1. LVSI and type of intrauterine manipulator

    Time frame: oct. 2015 - jan. 2021

    The effect of a type of an intrauterine manipulator on the incidence of LVSI

Other outcomes

  1. LVSI and grading of tumor

    Time frame: oct. 2015 - jan. 2021

    Connection between grading of tumor and incidence of LVSI

  2. LVSI and myometrial invasion

    Time frame: oct. 2015 - jan. 2021

    Connection between myometrial invasion of tumor and incidence of LVSI

  3. LVSI and primary histology procedure

    Time frame: oct. 2015 - jan. 2021

    Method of obtaining primary histology, hysteroscopy or curettage in connection to incidence of LVSI.

Sponsors and collaborators

Lead sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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