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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05261165
• Other study ID #: 29/2021
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: October 1, 2021

Study information

• Verified date: February 2022
• Source: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Slovakia	F.D. Roosevelt Teaching Hospital with Policlinic	Banská Bystrica

Sponsors (1)

Lead Sponsor	Collaborator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LVSI and grading of tumor	Connection between grading of tumor and incidence of LVSI	oct. 2015 - jan. 2021
Other	LVSI and myometrial invasion	Connection between myometrial invasion of tumor and incidence of LVSI	oct. 2015 - jan. 2021
Other	LVSI and primary histology procedure	Method of obtaining primary histology, hysteroscopy or curettage in connection to incidence of LVSI.	oct. 2015 - jan. 2021
Primary	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	LVSI and type of intrauterine manipulator	The effect of a type of an intrauterine manipulator on the incidence of LVSI	oct. 2015 - jan. 2021