About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Neoadjuvant therapy
Synchronous or previous (< 5 years) invasive cancer, not including non-melanoma skin cancer
Fertility preservation
World Health Organization performance score > 2
Trial design
Parallel
Treatments tested in this trial
Uterine manipulator use
DeviceThe uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence-free survival
Any recurrence or death related to endometrial cancer (EC) or treatment
Secondary outcomes
Cause-specific survival
Any death related to endometrial cancer (EC) or treatment
Overall survival
Any death for any cause
Site-specific recurrence-free survival
Any recurrence per site of first recurrence
Operative time
Time between first incision and skin closure
Sponsors and contacts
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