To hear about similar clinical trials, please enter your email below
Trial Title:
Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial
NCT ID:
NCT05687084
Condition:
Endometrial Neoplasms
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
Endometrial Neoplasms
Uterine manipulator
Laparoscopic hysterectomy
Recurrence-free survival
Cause-specific survival
Overall survival
Oncologic outcomes
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicenter, parallel arms, open-label, randomized controlled trial.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Uterine manipulator use
Description:
The uterine manipulator will be inserted into the uterus to assist in the procedure of
total hysterectomy.
Arm group label:
Total hysterectomy with a uterine manipulator
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Address:
City:
Verona
Zip:
37125
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Simone Garzon, MD
Start date:
January 16, 2023
Completion date:
December 31, 2031
Lead sponsor:
Agency:
Universita di Verona
Agency class:
Other
Source:
Universita di Verona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687084