Effect of a Uterine Manipulator on the Incidence of Lymphovascular Propagation (LVSI) in Treatment of Endometrial Cancer
Study Details
Study Description
Brief Summary
We retrospectively analyzed data and compared the impact of intrauterine manipulators on incidence of LVSI in endometrial cancer patients treated at our department.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| NonManip 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
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).
|
| Manip 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
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).
|
| ManipHe Subgroup of Manip group patients, in whome we used the Hegar's dilator as intrauterine manipulator. |
Procedure: hysterectomy
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).
|
| ManipKoRu Subgroup of Manip group patients, in whome we used the Koh-Rumi device as intrauterine manipulator. |
Procedure: hysterectomy
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).
|
Outcome Measures
Primary Outcome Measures
- LVSI and intrauterine manipulator [oct. 2015 - jan. 2021]
Finding of the difference in the incidence of LVSI in female patients with and without an intrauterine manipulator
Secondary Outcome Measures
- LVSI and type of intrauterine manipulator [oct. 2015 - jan. 2021]
The effect of a type of an intrauterine manipulator on the incidence of LVSI
Other Outcome Measures
- LVSI and grading of tumor [oct. 2015 - jan. 2021]
Connection between grading of tumor and incidence of LVSI
- LVSI and myometrial invasion [oct. 2015 - jan. 2021]
Connection between myometrial invasion of tumor and incidence of LVSI
- LVSI and primary histology procedure [oct. 2015 - jan. 2021]
Method of obtaining primary histology, hysteroscopy or curettage in connection to incidence of LVSI.
Eligibility Criteria
Criteria
Inclusion Criteria:
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endometrioid endometrial cancer,
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planned primary surgical treatment - hysterectomy,
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medical condition enabling anesthesia and surgery,
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pre-surgical clinically-determined affecting of the uterine according to MRI or ultrasound - cT1a or cT1b
Exclusion Criteria:
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non-endometrioid type of tumor in definitive histology,
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stage 2 of a disease and higher,
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previous chemo or radiotherapy,
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inability to adequately complete the surgery,
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uterine perforation during surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | F.D. Roosevelt Teaching Hospital with Policlinic | Banská Bystrica | Slovakia |
Sponsors and Collaborators
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 29/2021