NCT05687084 Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
| NCT ID | NCT05687084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita di Verona |
| Condition | Endometrial Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,030 participants |
| Start Date | 2023-01-16 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,030 participants in total. It began in 2023-01-16 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Criteria: * Neoadjuvant therapy * Synchronous or previous (\< 5 years) invasive cancer, not including non-melanoma skin cancer * Fertility preservation * World Health Organization performance score \> 2 * Uterine sarcoma * Previous pelvic/abdominal radiotherapy, hormone therapy for cancer (\< 5 years), chemotherapy (\< 5 years), pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery * 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) * Intraoperative evidence of stage IV disease
Contact & Investigator
Stefano Uccella, MD, PhD
PRINCIPAL INVESTIGATOR
AOUI Verona - University of Verona
Frequently Asked Questions
Who can join the NCT05687084 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Endometrial Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05687084 currently recruiting?
Yes, NCT05687084 is actively recruiting participants. Contact the research team at stefano.uccella@univr.it for enrollment information.
Where is the NCT05687084 trial being conducted?
This trial is being conducted at Cuneo, Italy, Reggio Emilia, Italy, Verona, Italy.
Who is sponsoring the NCT05687084 clinical trial?
NCT05687084 is sponsored by Universita di Verona. The principal investigator is Stefano Uccella, MD, PhD at AOUI Verona - University of Verona. The trial plans to enroll 1,030 participants.