Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Uterine manipulator use: The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

Study summary

Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.

Eligibility

Primary outcome measure(s)

• Recurrence-free survival — Each follow-up visit, up to 4 years from the day of surgery
  Any recurrence or death related to endometrial cancer (EC) or treatment

Trial sites (3)

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