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

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

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer; LVSI
• Intervention / Treatment: Procedure: hysterectomy

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 Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Slovakia
  • Banská Bystrica, Slovakia
    • F.D. Roosevelt Teaching Hospital with Policlinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women diagnosed with endometrial cancer, planned to primary surgical treatment - hysterectomy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
LVSI and type of intrauterine manipulator	The effect of a type of an intrauterine manipulator on the incidence of LVSI	oct. 2015 - jan. 2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LVSI and grading of tumor	Connection between grading of tumor and incidence of LVSI	oct. 2015 - jan. 2021
LVSI and myometrial invasion	Connection between myometrial invasion of tumor and incidence of LVSI	oct. 2015 - jan. 2021
LVSI and primary histology procedure	Method of obtaining primary histology, hysteroscopy or curettage in connection to incidence of LVSI.	oct. 2015 - jan. 2021

Collaborators and Investigators

• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 29/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No