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Endometrial NeoplasmsMANECNCT05687084

Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

A study testing Uterine manipulator use in people with Endometrial Neoplasms, run by Universita di Verona at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Endometrial Neoplasms
What is being tested?
Uterine manipulator use
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,030 participants
Where
3 sitesItaly
Study dates
16 Jan 2023to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

Italy3 sites, 3 recruiting

  • UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle

    Cuneo, Italy, 12100

    Andrea Puppo, Dr., 00000000000, puppo.a@ospedale.cuneo.it

    Recruiting

  • UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova

    Reggio Emilia

    Vincenzo Dario Mandato, Dr., 000000000, VincenzoDario.Mandato@ausl.re.it

    Recruiting

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

    Verona, 37125

    Simone Garzon, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Being tested
Uterine manipulator use
Keywords
Endometrial Neoplasms, Uterine manipulator, Laparoscopic hysterectomy, Recurrence-free survival, Cause-specific survival, Overall survival, Oncologic outcomes
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Uterine manipulator useDevice

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

Study groups in NCT05687084
Study groupRoleWhat they receive
Total hysterectomy with a uterine manipulatorExperimentalTotal hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.
Receives: Device: Uterine manipulator use
Total hysterectomy without a uterine manipulatorNo interventionTotal hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-free survival

    Any recurrence or death related to endometrial cancer (EC) or treatment

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

Secondary outcomes (9)

  1. Cause-specific survival

    Any death related to endometrial cancer (EC) or treatment

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

  2. Overall survival

    Any death for any cause

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

  3. Site-specific recurrence-free survival

    Any recurrence per site of first recurrence

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

  4. Operative time

    Time between first incision and skin closure

    Measured: Day of surgery

  5. Intraoperative blood loss

    Total blood aspirate during the surgical procedure

    Measured: Day of surgery

  6. 30-day post-surgical morbidity

    Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification

    Measured: 30 days after surgery

  7. Lymphovascular space invasion

    Presence of lymphovascular space invasion at definitive pathology

    Measured: Day of surgery

  8. Peritoneal cytology

    Presence of positive peritoneal cytology at definitive pathology

    Measured: Day of surgery

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start16 Jan 2023
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, parallel arms, open-label, randomized controlled trial.
Masking
None (open label)
Enrolment
1,030 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687084
Sponsor's protocol ID
MANEC Trial
Acronym
MANEC
Status last verified
Apr 2026
First submitted
6 Nov 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33397713

  • 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.

    PubMed 25967852

  • 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.

    PubMed 33207238

  • 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.

    PubMed 28147240

  • 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.

    PubMed 32693096

  • 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.

    PubMed 39266205

Questions about this trial

What is this clinical trial studying?

A study testing Uterine manipulator use in people with Endometrial Neoplasms, run by Universita di Verona at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stefano Uccella, MD, PhD (0039 045 812 2720, stefano.uccella@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free survival (time frame: Each follow-up visit, up to 4 years from the day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687084, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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