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Uterine Manipulator in Endometrial Cancer Surgery: Pro MUCEI Study

NCT05242276 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2023-10-10

No results posted yet for this study

Summary

The uterine manipulator is a device commonly used in minimally invasive hysterectomy surgery for endometrial cancer. However, without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience.

A retrospective study demonstrated how uterine manipulator use in early-stage endometrial cancer (FIGO I-II) for minimally invasive surgery was associated with a worse oncologic outcome in patients with uterus-confined endometrial cancer (FIGO I-II) who underwent minimally invasive surgery.

The main objective of this study is to prospectively confirm the results obtained retrospectively, assessing the relapse rate in these patients related to the use or not of a uterine manipulator during the endometrial surgery. Secondary, the presence of risk factors that contraindicate the use of the uterine manipulator will also be evaluated.

Conditions

Interventions

DEVICE

USE OF UTERINE MANIPULATOR DURING THE HYSTERECTOMY

The uterine manipulator is a device commonly used in minimally invasive hysterectomy surgery for endometrial cancer. However, without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience. . It is inserted vaginally through the cervical canal into the endometrial cavity. The uterine manipulator facilitates the uterus mobilization during the surgery, generating tension on the main supporting elements of the uterus to improve surgical field exposure and provide a landmark for the colpotomy.

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Principal Investigators

  • Pablo Padilla iserte, MD, PhD · Hospital Universitario La Fe

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-20
Primary Completion
2024-03-20
Completion
2026-03-20
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05242276 on ClinicalTrials.gov