Comparing uterine manipulator use in endometrial cancer surgery
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
This study is testing if using a uterine manipulator during surgery for endometrial cancer helps patients do better in the long run compared to surgery without it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1030 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Universita di Verona Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Cuneo, Italy and 2 other locations) |
| Trial ID | NCT05687084 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with endometrial cancer who are planning to undergo hysterectomy and bilateral salpingo-oophorectomy.
Not a fit: Patients with advanced-stage endometrial cancer, previous invasive cancers, or those requiring neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could clarify the safety of using a uterine manipulator in endometrial cancer surgeries, potentially improving surgical outcomes for patients.
How similar studies have performed: While the use of uterine manipulators is common in surgical procedures, this specific comparison in endometrial cancer has not been extensively tested, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cuneo, Italy and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.