Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial — MANEC  

Endometrial Neoplasms Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Endometrial Neoplasms

• NCT number: NCT05687084
• Study type: Interventional
• Source: Universita di Verona
• Contact: Stefano Uccella, MD, PhD
• Phone: 0039 045 812 2720
• Email: stefano.uccella@univr.it
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Completion date: December 31, 2031