Anthony Costales, MD
This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete your surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix). Even though the majority of surgeons use…
Inclusion Criteria: A subject will be considered eligible for inclusion in this study if all the following criteria are met: 1. Patient must be greater than or equal to 18 years old. 2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous) 3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively. 4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1). 6\. Signed informed consent and ability to comp…
The experimental group will have MIS with the placement of a uterine manipulator
The control group will have MIS without the placement of a uterine manipulator
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