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Completed

NCT Number: NCT02943811

Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

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

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical stage I endometrial cancer
  • Laparoscopic operation

Exclusion criteria

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

Treatment and study plan

UTERINE MANIPULATOR

Device

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

Primary outcomes

  1. Disease recurrence

    Time frame: 4 years

    Relapse of disease during follow-up

Secondary outcomes

  1. disease specific survival

    Time frame: 4 years

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

  2. overall survival

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 25, 2016
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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