Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

Trial Title: Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

NCT ID: NCT05687084

Condition: Endometrial Neoplasms

Conditions: Official terms:
Endometrial Neoplasms

Conditions: Keywords:
Endometrial Neoplasms
Uterine manipulator
Laparoscopic hysterectomy
Recurrence-free survival
Cause-specific survival
Overall survival
Oncologic outcomes

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Multicenter, parallel arms, open-label, randomized controlled trial.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Uterine manipulator use
Description: The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
Arm group label: Total hysterectomy with a uterine manipulator

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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Address:
City: Verona
Zip: 37125
Country: Italy

Status: Recruiting

Contact:
Last name: Simone Garzon, MD

Start date: January 16, 2023

Completion date: December 31, 2031

Lead sponsor:
Agency: Universita di Verona
Agency class: Other

Source: Universita di Verona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05687084