MANEC: Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

Sponsor

Universita di Verona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05687084

Collaborator

(none)

1,030

Enrollment

Location

Arms

106.9

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Neoplasms	Device: Uterine manipulator use	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1030 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter, parallel arms, open-label, randomized controlled trial.Multicenter, parallel arms, open-label, randomized controlled trial.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2031

Anticipated Study Completion Date :

Dec 31, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Total hysterectomy with a uterine manipulator Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.	Device: Uterine manipulator use After peritoneal washing, the uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
No Intervention: Total hysterectomy without a uterine manipulator Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.

Arm

Intervention/Treatment

Experimental: Total hysterectomy with a uterine manipulator

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

Device: Uterine manipulator use

After peritoneal washing, the uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

No Intervention: Total hysterectomy without a uterine manipulator

Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

Body Mass Index ≥ 45 Kg/m2
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, chemotherapy, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona		Italy	37125

Sponsors and Collaborators

Universita di Verona

Investigators

Principal Investigator: Stefano Uccella, MD, PhD, AOUI Verona - University of Verona
Principal Investigator: Simone Garzon, MD, AOUI Verona - University of Verona
Principal Investigator: Pier Carlo Zorzato, MD, AOUI Verona - University of Verona