NCT05261165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

5.3 years

First QC Date

February 19, 2022

Last Update Submit

February 19, 2022

Conditions

Endometrial CancerLVSI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • LVSI and type of intrauterine manipulator

    oct. 2015 - jan. 2021

Other Outcomes (3)

  • LVSI and grading of tumor

    oct. 2015 - jan. 2021

  • LVSI and myometrial invasion

    oct. 2015 - jan. 2021

  • LVSI and primary histology procedure

    oct. 2015 - jan. 2021

Study Arms (4)

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

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

ManipHe

Subgroup of Manip group patients, in whome we used the Hegar's dilator as intrauterine manipulator.

Procedure: hysterectomy

ManipKoRu

Subgroup of Manip group patients, in whome we used the Koh-Rumi device as intrauterine manipulator.

Procedure: hysterectomy

Interventions

hysterectomyPROCEDURE

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).

ManipManipHeManipKoRuNonManip

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

F.D. Roosevelt Teaching Hospital with Policlinic

Banská Bystrica, Slovakia

Location

Related Publications (1)

  • Hudec B, Dokus K, Urdzik P, Skolka R, Konarcikova T, Smitka M. Influence of uterine manipulator use on the incidence of lymphovascular propagation in the treatment of endometrial cancer. Minim Invasive Ther Allied Technol. 2023 Feb;32(1):12-17. doi: 10.1080/13645706.2022.2153342. Epub 2022 Dec 21.

    PMID: 36542513DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 2, 2022

Study Start

October 1, 2015

Primary Completion

January 1, 2021

Study Completion

October 1, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

SL(1)