Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial (MANEC)

April 28, 2026 updated by: Stefano Uccella, Universita di Verona

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1030

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Recruiting
        • UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova
        • Contact:
      • Verona, Italy, 37125
        • Recruiting
        • AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
        • Contact:
          • Simone Garzon, MD
    • Italy
      • Cuneo, Italy, Italy, 12100
        • Recruiting
        • UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total hysterectomy with a uterine manipulator
Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.
Device: Uterine manipulator use
The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.
No Intervention: Total hysterectomy without a uterine manipulator
Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
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
Each follow-up visit, up to 4 years from the day of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2023

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

November 6, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANEC Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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