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Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

Completed
Conditions
Endometrial Cancer
Interventions
Device: UTERINE MANIPULATOR
Registration Number
NCT02943811
Lead Sponsor
Università degli Studi dell'Insubria
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
951
Inclusion Criteria
  • Clinical stage I endometrial cancer
  • Laparoscopic operation
Exclusion Criteria
  • post-operative oncologic follow-up < 12 months
  • extra-uterine evidence of disease

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
MANIPULATORUTERINE MANIPULATORPatients who were operated for endometrial cancer by laparoscopy with the use of a uterine manipulator
Primary Outcome Measures
NameTimeMethod
Disease recurrence4 years

Relapse of disease during follow-up

Secondary Outcome Measures
NameTimeMethod
disease specific survival4 years

Kaplan Meyer curves and Log-rank test to explore disease-specific survival

overall survival4 years

Kaplan Meyer curves and Log-rank test to explore overall survival

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