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Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

NCT05687084 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2026-05-05

No results posted yet for this 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.

Conditions

  • Endometrial Neoplasms

Interventions

DEVICE

Uterine manipulator use

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

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Stefano Uccella, MD, PhD · AOUI Verona - University of Verona

  • Simone Garzon, MD · AOUI Verona - University of Verona

  • Pier Carlo Zorzato, MD · AOUI Verona - University of Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687084 on ClinicalTrials.gov