Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

NCT05687084 | Recruiting DMC

• 1 other identifier: MANEC Trial
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 3

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

Keywords

Endometrial Neoplasms; Uterine manipulator; Laparoscopic hysterectomy; Recurrence-free survival; Cause-specific survival; Overall survival; Oncologic outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cause-specific survival

  Each follow-up visit, up to 4 years from the day of surgery

• Overall survival

  Each follow-up visit, up to 4 years from the day of surgery

• Site-specific recurrence-free survival

  Each follow-up visit, up to 4 years from the day of surgery

• Operative time

  Day of surgery

• Intraoperative blood loss

  Day of surgery

Study Arms (2)

Total hysterectomy with a uterine manipulator

EXPERIMENTAL

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

Device: Uterine manipulator use

Total hysterectomy without a uterine manipulator

NO INTERVENTION

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

Interventions

Uterine manipulator use DEVICE

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

Total hysterectomy with a uterine manipulator

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (3)

UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle

Cuneo, Italy, 12100, Italy

RECRUITING

UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

RECRUITING

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

Verona, 37125, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 33397713 BACKGROUND

• 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.

  PMID: 25967852 BACKGROUND

• 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.

  PMID: 33207238 BACKGROUND

• 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.

  PMID: 28147240 BACKGROUND

• 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.

  PMID: 32693096 BACKGROUND

• 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.

  PMID: 39266205 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Uccella, MD, PhD

CONTACT

0039 045 812 2720; stefano.uccella@univr.it

Simone Garzon, MD

CONTACT

0039 045 812 2720; simone.garzon@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Stefano Uccella

Model Details: Multicenter, parallel arms, open-label, randomized controlled trial.

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: January 17, 2023
• Study Start: January 16, 2023
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)