Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

This study is looking at whether using a uterine manipulator (a device to move the uterus during surgery) during minimally invasive surgery for early stage endometrial cancer (cancer of the lining of the uterus) causes cancer cells to appear in the fluid around the uterus. You would be randomly assigned to one of two groups: one group will have surgery with a uterine manipulator, and the other group will have surgery without one. The study aims to see if there's a difference in the presence of cancer cells in the fluid collected during surgery between these two groups. To join, you must be a woman aged 18 to 90 with suspected early stage endometrial cancer. The study's success will be measured by whether there are cancer cells in the fluid collected during surgery. The current recruitment status is unclear.

Study design
This is a randomized study with 278 planned participants. You would be randomly assigned to one of two groups: surgery with a uterine manipulator or surgery without one.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, positive peritoneal cytology, is measured immediately after uterine manipulator placement in one group or prior to hysterectomy in the other.

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NCT04586959

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Recruiting
NAAges 18–90InterventionalTreatment
Anthony Costales, MD
~278 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:Surgery with UMSurgery without UM

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Positive peritoneal cytology (PC)
Measured over Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group
ENDOMETRIAL CANCER
5 sites across 2 states
Texas4
Ohio1
  • Anthony Costales, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

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  • Positive peritoneal cytology (PC)Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group

    Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.