Uterine Manipulator Versus No Uterine Manipulator in Endometrial Cancer Trial

Not Applicable

Recruiting

• Conditions: Endometrial Neoplasms
• Interventions: Device: Uterine manipulator use

• Registration Number: NCT05687084
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2023-01-13
• Study Start: 2023-01-16
• Study First Posted: 2023-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1030

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total hysterectomy with a uterine manipulator	Uterine manipulator use	Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Operative time	Day of surgery	Time between first incision and skin closure
Peritoneal cytology	Day of surgery	Presence of positive peritoneal cytology at definitive pathology
30-day post-surgical morbidity	30 days after surgery	Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification
Overall survival	Each follow-up visit, up to 4 years from the day of surgery	Any death for any cause
Intraoperative blood loss	Day of surgery	Total blood aspirate during the surgical procedure
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
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
Lymphovascular space invasion	Day of surgery	Presence of lymphovascular space invasion 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.

Trial Locations

Locations (3)

UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle; 🇮🇹 Cuneo, Italy

UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology; 🇮🇹 Verona, Italy