Uterine Manipulator Versus No Uterine Manipulator in Endometrial Cancer Trial

NCT ID: NCT05687084

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1030 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2031-12-31

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.

Conditions

Endometrial Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total hysterectomy with a uterine manipulator

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

Group Type: EXPERIMENTAL

Uterine manipulator use

Intervention Type: DEVICE

The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

Total hysterectomy without a uterine manipulator

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Uterine manipulator use

The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Stefano Uccella

Prof. Stefano Uccella

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Uccella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AOUI Verona - University of Verona

Simone Garzon, MD

Role: PRINCIPAL_INVESTIGATOR

AOUI Verona - University of Verona

Pier Carlo Zorzato, MD

Role: PRINCIPAL_INVESTIGATOR

AOUI Verona - University of Verona

Locations

UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle

Cuneo, Italy, Italy

Site Status: RECRUITING

UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status: RECRUITING

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Uccella, MD, PhD

Role: CONTACT

stefano.uccella@univr.it

0039 045 812 2720

Simone Garzon, MD

Role: CONTACT

simone.garzon@univr.it

0039 045 812 2720

Facility Contacts

Andrea Puppo, Dr.

Role: primary

puppo.a@ospedale.cuneo.it

00000000000

Vincenzo Dario Mandato, Dr.

Role: primary

VincenzoDario.Mandato@ausl.re.it

000000000

Simone Garzon, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 33397713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25967852 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33207238 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28147240 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32693096 (View on PubMed)

Uccella S, Puppo A, Ghezzi F, Zorzato PC, Ceccaroni M, Mandato VD, Berretta R, Camanni M, Seracchioli R, Perrone AM, Chiantera V, Vizzielli G, Sozzi G, Beretta P, Steinkasserer M, Legge F, Stevenazzi G, Candotti G, Bergamini V, Fanfani F, Garzon S. A randomized controlled trial on the oncologic outcomes of use of the intrauterine manipulator in the treatment of apparent uterine-confined endometrial carcinoma: the MANEC Trial. Int J Gynecol Cancer. 2024 Dec 2;34(12):1971-1975. doi: 10.1136/ijgc-2024-005668.

Reference Type: DERIVED

PMID: 39266205 (View on PubMed)

Other Identifiers

MANEC Trial

Identifier Type: -

Identifier Source: org_study_id