Endometrial Neoplasms
Conditions
Keywords
Endometrial Neoplasms, Uterine manipulator, Laparoscopic hysterectomy, Recurrence-free survival, Cause-specific survival, Overall survival, Oncologic outcomes
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.
Interventions
DEVICEUterine manipulator use
The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, parallel arms, open-label, randomized controlled trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | Each follow-up visit, up to 4 years from the day of surgery | Any recurrence or death related to endometrial cancer (EC) or treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cause-specific survival | Each follow-up visit, up to 4 years from the day of surgery | Any death related to endometrial cancer (EC) or treatment |
| Overall survival | Each follow-up visit, up to 4 years from the day of surgery | Any death for any cause |
| Site-specific recurrence-free survival | Each follow-up visit, up to 4 years from the day of surgery | Any recurrence per site of first recurrence |
| Operative time | Day of surgery | Time between first incision and skin closure |
| Intraoperative blood loss | Day of surgery | Total blood aspirate during the surgical procedure |
| 30-day post-surgical morbidity | 30 days after surgery | Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification |
| Lymphovascular space invasion | Day of surgery | Presence of lymphovascular space invasion at definitive pathology |
| Peritoneal cytology | Day of surgery | Presence of positive peritoneal cytology at definitive pathology |
| Quality of life indexes | Each follow-up visit, up to 4 years from the day of surgery | The Functional Assessment of Cancer Therapy - General (FACT-G) - A 27-item questionnaire designed to measure four domains of Health-Related Quality of Life in cancer patients: Physical, social, emotional, and functional well-being. Score range 0-108. The higher the score, the better the Quality of Life. |
Countries
Italy
Contacts
CONTACTStefano Uccella, MD, PhD
CONTACTSimone Garzon, MD
PRINCIPAL_INVESTIGATORStefano Uccella, MD, PhD
AOUI Verona - University of Verona
PRINCIPAL_INVESTIGATORSimone Garzon, MD
AOUI Verona - University of Verona
PRINCIPAL_INVESTIGATORPier Carlo Zorzato, MD
AOUI Verona - University of Verona
Outcome results
None listed