Tests use of a uterine manipulator during surgery for endometrial cancer
Compares surgery with or without a uterine manipulator in women with uterine cancer.
Plain-language title generated from the registry record
Registry title: Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
Key facts
- Where
- Cuneo, Reggio Emilia, and Verona, ItalySee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT05687084, who can take part
Where in Italy
- UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e CarleCuneo, ItalyTaking people
- UOC Ostetricia e Ginecologia, Arcispedale Santa Maria NuovaReggio Emilia, ItalyTaking people
- AOUI Verona - University of Verona - Department of Obstetrics and GynecologyVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universita di Verona
- Trial code
- NCT05687084
- Record updated
- 5 May 2026
- Original 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.Read full original descriptionShow less
Randomized Controlled Trial on the Oncologic Outcomes of Use Versus Not Use of the Uterine Manipulator in the Surgical Treatment of Apparent Uterine-confined Endometrial Carcinoma
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.
Inclusion: 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: Neoadjuvant therapy; Synchronous or previous (< 5 years) invasive cancer, not including non-melanoma skin cancer; Previous pelvic/abdominal radiotherapy, hormone therapy for cancer (< 5 years), chemotherapy (< 5 years), pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery; Intraoperative evidence of stage IV disease; 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); Fertility preservation; World Health Organization performance score > 2; Uterine sarcoma.