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

Completed

• Conditions: Endometrial Cancer; LVSI

• Registration Number: NCT05261165
• Lead Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

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.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-10-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-02-19
• Last Update Submitted: 2022-02-19
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
LVSI and type of intrauterine manipulator	oct. 2015 - jan. 2021	The effect of a type of an intrauterine manipulator on the incidence of LVSI

Trial Locations

Locations (1)

F.D. Roosevelt Teaching Hospital with Policlinic; 🇸🇰 Banská Bystrica, Slovakia