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NCT Number: NCT05687084

Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uterine manipulator use

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Overall survival

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

    Any death for any cause

  3. 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

  4. Operative time

    Time frame: Day of surgery

    Time between first incision and skin closure

  5. Intraoperative blood loss

    Time frame: Day of surgery

    Total blood aspirate during the surgical procedure

  6. 30-day post-surgical morbidity

    Time frame: 30 days after surgery

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

  7. Lymphovascular space invasion

    Time frame: Day of surgery

    Presence of lymphovascular space invasion at definitive pathology

  8. Peritoneal cytology

    Time frame: Day of surgery

    Presence of positive peritoneal cytology at definitive pathology

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simone Garzon, MD

CONTACT

[email protected]

0039 045 812 2720

Stefano Uccella, MD, PhD

CONTACT

[email protected]

0039 045 812 2720

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study 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

Acronym: MANEC

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Jan 17, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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