RecruitingNot ApplicableNCT05687084

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


Sponsor

Universita di Verona

Enrollment

1,030 participants

Start Date

Jan 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical techniques for treating endometrial (uterine) cancer: removing the uterus with a uterine manipulator (a tool inserted inside the uterus to help position it during surgery) versus removing it without one. Researchers want to know if the manipulator affects cancer outcomes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with endometrial cancer (any type or grade) - You are scheduled for a hysterectomy and removal of both ovaries and tubes as treatment - There is no sign that your cancer has spread beyond the uterus before surgery **You may NOT be eligible if...** - You have received neoadjuvant (pre-surgery) therapy - You have had another invasive cancer in the past 5 years (other than non-melanoma skin cancer) - You have uterine sarcoma - You have had prior pelvic radiation, hormone therapy for cancer, or chemotherapy in the past 5 years - Your blood counts, liver, or kidney function are significantly impaired - You want to preserve fertility Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUterine manipulator use

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


Locations(3)

UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle

Cuneo, Italy, Italy

UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, Italy

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NCT05687084


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