Actively Recruiting
Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
Led by Universita di Verona · Updated on 2026-05-05
1030
Participants Needed
3
Research Sites
467 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of endometrial cancer of any histology and grade
- Planned surgery including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation allowed in some cases)
- Age 18 years or older
- No preoperative signs of extrauterine disease (clinical stage IIIA, IIIB)
- No preoperative signs of suspicious lymph nodes (clinical stage IIIC)
- No preoperative signs of distant metastasis (clinical stage IV)
- Signed informed consent approved by the study team
You will not qualify if you...
- Received neoadjuvant therapy
- Synchronous or previous invasive cancer within 5 years, excluding non-melanoma skin cancer
- Fertility preservation plans
- World Health Organization performance score greater than 2
- Diagnosis of uterine sarcoma
- Previous pelvic or abdominal radiotherapy, hormone therapy for cancer within 5 years, chemotherapy within 5 years, pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery
- Inadequate bone marrow function (white blood cells less than 3.0 x 10^9/L, platelets less than 100 x 10^9/L)
- Inadequate liver function (bilirubin above 1.5 times upper normal limit, AST and ALT above 2.5 times upper normal limit)
- Inadequate kidney function (creatinine clearance less than 60 mL/min by Cockcroft-Gault or less than 50 mL/min by EDTA clearance)
- Evidence during surgery of stage IV disease
AI-Screening
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Trial Site Locations
Total: 3 locations
1
UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle
Cuneo, Italy, Italy, 12100
Actively Recruiting
2
UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Actively Recruiting
3
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, Italy, 37125
Actively Recruiting
Research Team
S
Stefano Uccella, MD, PhD
CONTACT
S
Simone Garzon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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