Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

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Description

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.

Targeted Conditions

Study Overview

Start Date
January 16, 2023
Completion Date
December 31, 2031
Enrollment
1030
Date Posted
January 17, 2023
Accepts Healthy Volunteers?
No
Gender
Female

Locations

Full Address
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona 37125, Italy

Eligibility

Minimum Age (years)
18
Maximum Age (years)
100
Eligibility Criteria
Inclusion Criteria:

Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade
Planned surgical treatment including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion)
Age ≥ 18 years
No preoperative evidence of extrauterine disease (Clinical stage IIIA, IIIB)
No preoperative evidence of suspicious lymph nodes (Clinical stage IIIC)
No preoperative evidence of distant metastasis (Clinical stage IV)
Approved and signed informed consent

Exclusion Criteria:

Neoadjuvant therapy
Synchronous or previous (< 5 years) invasive cancer, not including non-melanoma skin cancer
Fertility preservation
World Health Organization performance score > 2
Uterine sarcoma
Previous pelvic/abdominal radiotherapy, hormone therapy for cancer (< 5 years), chemotherapy (< 5 years), pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery
Inadequate bone marrow function (white blood cells <3·0×109/L, platelets <100×109/L)
Inadequate liver function (bilirubin >1.5×upper normal limit [UNL], aspartate aminotransferase, and alanine aminotransferase >2.5 × UNL)
Inadequate kidney function (creatinine clearance < 60 mL per min calculated according to Cockcroft-Gault 10 or < 50 mL per min Ethylenediaminetetraacetic acid clearance)
Intraoperative evidence of stage IV disease

Study Contact Info

Study Contact Name
Stefano Uccella, MD, PhD; Simone Garzon, MD

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05687084