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

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

Detailed Description
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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.

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

Conditions
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LVSI, Endometrial Cancer

Intervention / Treatment
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* Procedure: hysterectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NonManip<br>In the group of female patients operated without a uterine manipulator (NonManip), we included the female patients who were operated by abdominal approach without no need to use a manipulator. These female patients did not meet the predominantly anesthesiological requirements for the tolerance of the Trendelenburg position; respectively, the likelihood of adhesions in the abdominal cavity after previous laparotomy operations was there. Therefore, from a safety point of view, due to the risk of damage to the abdominal organs and the need for extensive adhesiolysis, the primary endoscopic surgery was not performed. | Procedure: hysterectomy<br>* 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).<br>|
| Manip<br>The female patients suitable for endoscopic performance to laparoscopic, respectively the robotic hysterectomies, in whom the use of a uterine manipulator (Manip) was planned, were assigned random into two groups. | Procedure: hysterectomy<br>* 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).<br>|
| ManipHe<br>Subgroup of Manip group patients, in whome we used the Hegar's dilator as intrauterine manipulator. | Procedure: hysterectomy<br>* 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).<br>|
| ManipKoRu<br>Subgroup of Manip group patients, in whome we used the Koh-Rumi device as intrauterine manipulator. | Procedure: hysterectomy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVSI and intrauterine manipulator | Finding of the difference in the incidence of LVSI in female patients with and without an intrauterine manipulator | oct. 2015 - jan. 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVSI and type of intrauterine manipulator | The effect of a type of an intrauterine manipulator on the incidence of LVSI | oct. 2015 - jan. 2021 |