Uterine manipulator use
DeviceThe uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
NCT Number: NCT05687084
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.
Interested in participating?
Request Info18 year–100 year
Female
Interventional
Not applicable
UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
Time frame: Each follow-up visit, up to 4 years from the day of surgery
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
Any death related to endometrial cancer (EC) or treatment
Time frame: Each follow-up visit, up to 4 years from the day of surgery
Any death for any cause
Time frame: Each follow-up visit, up to 4 years from the day of surgery
Any recurrence per site of first recurrence
Time frame: Day of surgery
Time between first incision and skin closure
Time frame: Day of surgery
Total blood aspirate during the surgical procedure
Time frame: 30 days after surgery
Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification
Time frame: Day of surgery
Presence of lymphovascular space invasion at definitive pathology
Time frame: Day of surgery
Presence of positive peritoneal cytology at definitive pathology
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Simone Garzon, MD
CONTACT
Stefano Uccella, MD, PhD
CONTACT
Universita di Verona
Other
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
Acronym: MANEC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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