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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05261165
Enrollment
170
Registered
2022-03-02
Start date
2015-10-01
Completion date
2021-10-01
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, LVSI

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.

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.

Interventions

PROCEDUREhysterectomy

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).

Sponsors

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
LVSI and intrauterine manipulatoroct. 2015 - jan. 2021Finding of the difference in the incidence of LVSI in female patients with and without an intrauterine manipulator

Secondary

MeasureTime frameDescription
LVSI and type of intrauterine manipulatoroct. 2015 - jan. 2021The effect of a type of an intrauterine manipulator on the incidence of LVSI

Other

MeasureTime frameDescription
LVSI and grading of tumoroct. 2015 - jan. 2021Connection between grading of tumor and incidence of LVSI
LVSI and myometrial invasionoct. 2015 - jan. 2021Connection between myometrial invasion of tumor and incidence of LVSI
LVSI and primary histology procedureoct. 2015 - jan. 2021Method of obtaining primary histology, hysteroscopy or curettage in connection to incidence of LVSI.

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026