Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

Università degli Studi dell'Insubria

Status: Completed

Conditions: Endometrial Cancer

Treatments: Device: UTERINE MANIPULATOR

Study type: Observational

Funder types: Other

Identifiers

NCT02943811

521

Details and patient eligibility

About

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

Full 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.

Enrollment: 951 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical stage I endometrial cancer
• Laparoscopic operation

Exclusion criteria

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

Trial design

951 participants in 2 patient groups

MANIPULATOR

Description:

Patients who were operated for endometrial cancer by laparoscopy with the use of a uterine manipulator

Treatment:

Device: UTERINE MANIPULATOR

NO MANIPULATOR

Description:

Patients who were operated for endometrial cancer by laparoscopy without the use of a uterine manipulator