Comparing uterine manipulator use in endometrial cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of using a uterine manipulator during laparoscopic hysterectomy in patients with endometrial cancer. It aims to determine whether the use of the manipulator affects oncologic outcomes, such as recurrence-free survival and cause-specific survival, compared to surgery without the manipulator. The study will enroll patients diagnosed with endometrial cancer who are scheduled for surgical treatment, ensuring they meet specific eligibility criteria. By comparing these two approaches, the trial seeks to provide high-quality evidence regarding the safety and efficacy of uterine manipulator use in this context.

Why it matters

Who can join: the full rules

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

Where it's running

• UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle
  Cuneo, Italy, Italy Recruiting
• UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova
  Reggio Emilia, Italy Recruiting
• AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
  Verona, Italy Recruiting

Study contacts

• Principal investigator: Stefano Uccella, MD, PhD — AOUI Verona - University of Verona
• Study coordinator: Stefano Uccella, MD, PhD
• Email: stefano.uccella@univr.it
• Phone: 0039 045 812 2720

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.