About this trial
This study aims to answer whether use of a Vcare® intrauterine manipulator leads to an increased incidence of positive peritoneal cytology in patients undergoing surgical management of early stage (FIGO stage I/II) endometrial cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects age 18 or older able to give informed consent
Biopsy diagnosed endometrial cancer (including endometrioid, serous, mucinous and clear cell histologies)
Planned standard of care surgical management of early stage endometrial cancer
No clinical evidence of disseminated intraperitoneal disease
Disqualifiers
Final pathology does not reflect diagnosis of endometrial cancer (including endometrioid, serous, mucinous, and clear cell histology)
Evidence of disseminated intraperitoneal disease
Subject is not a surgical candidate
Subject elects for fertility sparing or non-operative management
Trial design
Parallel
Treatments tested in this trial
surgical staging
Procedure/SurgeryPatients will undergo standard surgical staging for endometrial cancer utilizing either a V-care uterine manipulator or sponge stick
Treatment groups
Trial outcomes
Primary outcomes
Conversion of positive peritoneal cytology
Intraoperative conversion rate from negative to positive peritoneal cytology will be assessed in each arm
Secondary outcomes
Recurrence rate
Endometrial cancer rates at 2 years from surgery will be assessed
Sponsors and contacts
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