Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorUniversita di Verona

About this trial

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

Qualifiers

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)

Disqualifiers

Neoadjuvant therapy

Synchronous or previous (< 5 years) invasive cancer, not including non-melanoma skin cancer

Fertility preservation

World Health Organization performance score > 2

Trial design

Treatments tested in this trial

  • Uterine manipulator use

Treatment groups

1,030 Participants
are divided into 2 treatment groups

Sponsors and collaborators