A Prospective Study of the Impact of Uterine Manipulator on Oncological Outcome in Endometrial Cancer Surgery in Early-stage: Pro MUCEI Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• \- Women with endometrial cancer diagnosed with stage I-II.

• \- Previous pre-surgical biopsy with a diagnosis of endometrial cancer.

• \- The surgery has been performed and there are complete data on surgery, pathological anatomy, and follow-up of at least 2 years.

Locations
Other Locations
Spain
Hospital universitario y politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
Pablo Padilla iserte, MD, PhD
oncogine_lafe@gva.es
961244000
Backup
Santiago Domingo del Pozo, MD, PhD
oncogine_lafe@gva.es
961244000
Time Frame
Start Date: 2022-03-20
Estimated Completion Date: 2026-03-20
Participants
Target number of participants: 1200
Treatments
uterine manipulator cohort
Patients with early-stage endometrial cancer who have performed a hysterectomy with a uterine manipulator to mobilize the uterus during the surgery.
no uterine manipulator cohort
Patients with early-stage endometrial cancer who have performed a hysterectomy without a uterine manipulator to mobilize the uterus during the surgery.
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigacion Sanitaria La Fe

This content was sourced from clinicaltrials.gov

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