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Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer: a Multi-centric Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02943811
Enrollment
951
Registered
2016-10-25
Start date
2016-10-31
Completion date
2016-10-31
Last updated
2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

endometrial cancer, survival, uterine manipulator

Brief summary

The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer

Detailed description

The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis. Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.

Interventions

Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Clinical stage I endometrial cancer * Laparoscopic operation

Exclusion criteria

* post-operative oncologic follow-up \< 12 months * extra-uterine evidence of disease

Design outcomes

Primary

MeasureTime frameDescription
Disease recurrence4 yearsRelapse of disease during follow-up

Secondary

MeasureTime frameDescription
disease specific survival4 yearsKaplan Meyer curves and Log-rank test to explore disease-specific survival
overall survival4 yearsKaplan Meyer curves and Log-rank test to explore overall survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026