Intrauterine Manipulator Use and Peritoneal Cytology in Endometrial Cancer
This study is looking at whether using a V-care® intrauterine manipulator during surgery for early-stage endometrial cancer (cancer of the lining of the uterus) might increase the chance of finding cancer cells in the fluid around the organs in your belly (positive peritoneal cytology). Endometrial cancer is common, and while most cases are found early, some patients experience recurrence. Researchers want to see if positive peritoneal cytology, which has been linked to worse outcomes, is more common when a V-care® intrauterine manipulator is used compared to a sponge stick during surgery. You may be able to join if you are 18 or older, have been diagnosed with endometrial cancer by biopsy, are planning standard surgery for early-stage endometrial cancer, and do not have signs of widespread cancer in your belly. The study will measure positive peritoneal cytology after 2 years.
- Study design
- This is an interventional study planning to enroll 350 women. It compares two surgical tools used during endometrial cancer surgery.
- What's involved
- Patients will undergo standard surgical staging for endometrial cancer, using either a V-care uterine manipulator or a sponge stick.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, conversion of positive peritoneal cytology, will be measured at 2 years.
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Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Eav Lim, DO · PRINCIPAL_INVESTIGATOR · WellSpan Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Conversion of positive peritoneal cytology2 years
Intraoperative conversion rate from negative to positive peritoneal cytology will be assessed in each arm