Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer — MAN-U  

ENDOMETRIAL CANCER Clinical Trial

Official title: Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• ENDOMETRIAL CANCER
• Endometrial Neoplasms

• NCT number: NCT04586959
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Anthony Costales, MD
• Phone: 713-798-3495
• Email: costales@bcm.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Completion date: October 2025