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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle
RECRUITING
Cuneo
UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova
RECRUITING
Reggio Emilia
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
RECRUITING
Verona
Contact Information
Primary
Stefano Uccella, MD, PhD
stefano.uccella@univr.it
0039 045 812 2720
Backup
Simone Garzon, MD
simone.garzon@univr.it
0039 045 812 2720
Time Frame
Start Date: 2023-01-16
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 1030
Treatments
Experimental: Total hysterectomy with a uterine manipulator
Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.
No_intervention: Total hysterectomy without a uterine manipulator
Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.
Related Therapeutic Areas
Sponsors
Leads: Universita di Verona

This content was sourced from clinicaltrials.gov

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