Uterine Manipulator Versus No Uterine Manipulator in Endometrial Cancer Trial

Launched by UNIVERSITA DI VERONA · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is examining whether using a uterine manipulator during minimally invasive surgery for endometrial cancer (EC) affects patient outcomes compared to not using one. The uterine manipulator is a tool that helps doctors perform surgeries more easily, but there are concerns that it might increase the risk of spreading cancer cells. By comparing the results of patients who undergo surgery with and without this tool, the researchers hope to find out if it is safe and effective to use during surgery for EC.

To be eligible for this trial, participants must be women aged 18 or older who have been diagnosed with endometrial cancer and are planning to have a hysterectomy (removal of the uterus) along with the removal of ovaries. They should not have any signs of cancer spreading outside the uterus or other serious health issues. Those who join the trial can expect close monitoring throughout their treatment and will help contribute valuable information that may improve surgical practices for future patients with endometrial cancer.

Gender

FEMALE

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