NCT05687084

Uterine Manipulator Versus No Uterine Manipulator in Endometrial Cancer Trial

Randomized Controlled Trial on the Oncologic Outcomes of Use Versus Not Use of the Uterine Manipulator in the Surgical Treatment of Apparent Uterine-confined Endometrial Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,030 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Neoplasms

Interventions

Type	Name	Description
DEVICE	Uterine manipulator use	The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

Timeline

• Start date: 2023-01-16
• Primary completion: 2031-12-31
• Completion: 2031-12-31
• First posted: 2023-01-17
• Last updated: 2025-03-07

Locations

3 sites across 1 country: Italy