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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Uterine manipulator use

    Device

    The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

Treatment groups

1,030 Participants
are divided into 2 treatment groups
Group A: Total hysterectomy with a uterine manipulatorExperimental treatment 1 intervention
Group B: Total hysterectomy without a uterine manipulatorNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recurrence-free survival

Any recurrence or death related to endometrial cancer (EC) or treatment

Time frame
Each follow-up visit, up to 4 years from the day of surgery

Secondary outcomes

1

Cause-specific survival

Any death related to endometrial cancer (EC) or treatment

Time frame
Each follow-up visit, up to 4 years from the day of surgery
2

Overall survival

Any death for any cause

Time frame
Each follow-up visit, up to 4 years from the day of surgery
3

Site-specific recurrence-free survival

Any recurrence per site of first recurrence

Time frame
Each follow-up visit, up to 4 years from the day of surgery
4

Operative time

Time between first incision and skin closure

Time frame
Day of surgery

Other outcomes

Sponsors and contacts

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