Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

Endometrial Neoplasms Clinical Trial

— MANEC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687084
• Other study ID #: MANEC Trial
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2031

Study information

• Verified date: February 2024
• Source: Universita di Verona
• Contact: Stefano Uccella, MD, PhD
• Phone: 0039 045 812 2720
• Email: stefano.uccella[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1030
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Device:
• Uterine manipulator use
The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

Locations

Country	Name	City	State
Italy	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18. — View Citation

Padilla-Iserte P, Lago V, Tauste C, Diaz-Feijoo B, Gil-Moreno A, Oliver R, Coronado P, Martin-Salamanca MB, Pantoja-Garrido M, Marcos-Sanmartin J, Gilabert-Estelles J, Lorenzo C, Cazorla E, Roldan-Rivas F, Rodriguez-Hernandez JR, Sanchez L, Muruzabal JC, Hervas D, Domingo S; Spanish Society of Gynecology and Obstetrics Spanish Investigational Network Gynecologic Oncology Group. Impact of uterine manipulator on oncological outcome in endometrial cancer surgery. Am J Obstet Gynecol. 2021 Jan;224(1):65.e1-65.e11. doi: 10.1016/j.ajog.2020.07.025. Epub 2020 Jul 18. — View Citation

Uccella S, Bonzini M, Malzoni M, Fanfani F, Palomba S, Aletti G, Corrado G, Ceccaroni M, Seracchioli R, Shakir F, Ferrero A, Berretta R, Tinelli R, Vizza E, Roviglione G, Casarella L, Volpi E, Cicinelli E, Scambia G, Ghezzi F. The effect of a uterine manipulator on the recurrence and mortality of endometrial cancer: a multi-centric study by the Italian Society of Gynecological Endoscopy. Am J Obstet Gynecol. 2017 Jun;216(6):592.e1-592.e11. doi: 10.1016/j.ajog.2017.01.027. Epub 2017 Jan 29. — View Citation

Uccella S, Cianci S, Gueli Alletti S. Uterine manipulator in endometrial cancer: we are still far from the answer. Am J Obstet Gynecol. 2021 Mar;224(3):332. doi: 10.1016/j.ajog.2020.09.049. Epub 2020 Nov 15. No abstract available. — View Citation

van den Haak L, Alleblas C, Nieboer TE, Rhemrev JP, Jansen FW. Efficacy and safety of uterine manipulators in laparoscopic surgery: a review. Arch Gynecol Obstet. 2015 Nov;292(5):1003-11. doi: 10.1007/s00404-015-3727-9. Epub 2015 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	Any recurrence or death related to endometrial cancer (EC) or treatment	Each follow-up visit, up to 4 years from the day of surgery
Secondary	Cause-specific survival	Any death related to endometrial cancer (EC) or treatment	Each follow-up visit, up to 4 years from the day of surgery
Secondary	Overall survival	Any death for any cause	Each follow-up visit, up to 4 years from the day of surgery
Secondary	Site-specific recurrence-free survival	Any recurrence per site of first recurrence	Each follow-up visit, up to 4 years from the day of surgery
Secondary	Operative time	Time between first incision and skin closure	Day of surgery
Secondary	Intraoperative blood loss	Total blood aspirate during the surgical procedure	Day of surgery
Secondary	30-day post-surgical morbidity	Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification	30 days after surgery
Secondary	Lymphovascular space invasion	Presence of lymphovascular space invasion at definitive pathology	Day of surgery
Secondary	Peritoneal cytology	Presence of positive peritoneal cytology at definitive pathology	Day of surgery
Secondary	Quality of life indexes	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.	Each follow-up visit, up to 4 years from the day of surgery