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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,030
The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle
Cuneo, Italy, Italy
RECRUITINGUOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
RECRUITINGAOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, Italy
RECRUITINGRecurrence-free survival
Any recurrence or death related to endometrial cancer (EC) or treatment
Time frame: Each follow-up visit, up to 4 years from the day of surgery
Cause-specific survival
Any death related to endometrial cancer (EC) or treatment
Time frame: Each follow-up visit, up to 4 years from the day of surgery
Overall survival
Any death for any cause
Time frame: Each follow-up visit, up to 4 years from the day of surgery
Site-specific recurrence-free survival
Any recurrence per site of first recurrence
Time frame: Each follow-up visit, up to 4 years from the day of surgery
Operative time
Time between first incision and skin closure
Time frame: Day of surgery
Intraoperative blood loss
Total blood aspirate during the surgical procedure
Time frame: Day of surgery
30-day post-surgical morbidity
Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification
Time frame: 30 days after surgery
Lymphovascular space invasion
Presence of lymphovascular space invasion at definitive pathology
Time frame: Day of surgery
Peritoneal cytology
Presence of positive peritoneal cytology at definitive pathology
Time frame: Day of surgery
Quality of life indexes
The Functional Assessment of Cancer Therapy - General (FACT-G) - A 27-item questionnaire designed to measure four domains of Health-Related Quality of Life in cancer patients: Physical, social, emotional, and functional well-being. Score range 0-108. The higher the score, the better the Quality of Life.
Time frame: Each follow-up visit, up to 4 years from the day of surgery
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