NCT05687084Recruiting
Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
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
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1030 (estimated)
- First submitted
- 6 Nov 2022
- Start date
- 16 Jan 2023
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Universita di Verona
- Diseases
- Endometrial cancer
- NCT number
- NCT05687084
What you commit to
- Study type: Interventional
- Planned participants: 1030
- From 16 Jan 2023 to the primary completion date, 31 Dec 2031
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Intraoperative evidence of stage IV disease
Lab values
- 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)
Other
- Fertility preservation
- World Health Organization performance score \> 2
- Uterine sarcoma
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle Coordinator of this site? Confirm its status | Cuneo | Italy | Recruiting |
| UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| AOUI Verona - University of Verona - Department of Obstetrics and Gynecology Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.