An interventional study of Surgery with UM and Surgery without UM in ENDOMETRIAL CANCER, sponsored by Anthony Costales, MD. Recruiting at 5 sites in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-10-15.
Sponsored by Anthony Costales, MD · Not applicable, Interventional, and Treatment
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 a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back.
Currently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen.
The purpose of this study is to see 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.
A computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator.
Researchers will use the information from this study to decide how best to take care of patients undergoing minimally invasive surgery for uterine cancer.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 278 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →This is the only study on the registry with Anthony Costales, MD as lead sponsor.
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A subject will be considered eligible for inclusion in this study if all the following criteria are met:
6. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure.
Exclusion Criteria:
A subject must not have any of the following criteria:
Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)
Device: Surgery with UM
Subjects that undergo a MIS approach without a uterine manipulator (control arm)
Device: Surgery without UM
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
Positive peritoneal cytology (PC)
Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.
Time frame: Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group
Post-operative positive PC
Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.
Time frame: Immediately after closure of the vaginal cuff
Lymphovascular space invasion (LVSI)
LVSI is defined as the presence of tumor cells within a definite endothelial-lined space (lymphatics or blood vessels) at the advancing edge of the tumor as it invades the myometrium, within an endometrial polyp, or within the endometrial stroma.
Time frame: During surgery
Percentage of myometrial invasion (MI)
Defined as the % of invasion into the myometrium from the endomyometrial junction
Time frame: During surgery
Extent of lymph node metastases
Defined as presence of isolated tumor cells (ITC - \<0.2 mm), or micrometastasis (mm - 0.2 - 2 mm), or macrometastasis (MM - \> 2 mm), whichever is greater.
Time frame: During surgery
Operative time
Defined as time from start of operation to closure of skin in minutes as documented in the electronic medical record
Time frame: 1 day
Surgical morbidity
Surgical morbidity (CTCAE v5.0) grade 3 and higher, or any grade of the following adverse events: colonic fistula, colonic perforation, enterovesical fistula, gastrointestinal fistula, ileus, intra-abdominal hemorrhage, rectal fistula, rectal perforation, small intestinal perforation, abdominal infection, pelvic infection, vaginal infection, intra-operative arterial injury, venous injury, intra-operative gastrointestinal injury, intra-operative hemorrhage, intra-operative neurological injury, intra-operative urinary injury, and post-operative hemorrhage.
Time frame: Intra-operative and up to 30 days post-surgery
Plan to share: No
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