NCT05261165

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 170 (actual)
• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer
• LVSI

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-10-01
• Primary completion: 2021-01-01
• Completion: 2021-10-01
• First posted: 2022-03-02
• Last updated: 2022-03-02

Locations

1 site across 1 country: Slovakia