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Uterine Manipulator in Endometrial Cancer Surgery: Pro MUCEI Study

RECRUITINGSponsored by Instituto de Investigacion Sanitaria La Fe
Actively Recruiting
SponsorInstituto de Investigacion Sanitaria La Fe
Started2022-03-20
Est. completion2024-03-20
Eligibility
SexFEMALE
Healthy vol.Accepted

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

Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

1. \- Women with endometrial cancer diagnosed with stage I-II.
2. \- Previous pre-surgical biopsy with a diagnosis of endometrial cancer.
3. \- The surgery has been performed and there are complete data on surgery, pathological anatomy, and follow-up of at least 2 years.

Exclusion Criteria:

* Any patient with suspected disease beyond the uterus in the preoperative assessment or confirmed during surgical exploration. Cases without pathological confirmation of endometrial cancer in the final surgical specimen or final histology of atypical hyperplasia/endometrial intraepithelial neoplasia will not be accepted.

Patients with open surgery, conversion to laparotomy, or vaginal hysterectomy alone will also be excluded.

Conditions2

CancerEndometrial Cancer

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