Status:
RECRUITING
Uterine Manipulator in Endometrial Cancer Surgery: Pro MUCEI Study
Lead Sponsor:
Instituto de Investigacion Sanitaria La Fe
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
Brief 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 ...
Detailed Description
The primary treatment for early-stage endometrial cancer is surgery, performing a total hysterectomy and bilateral salpingo-oophorectomy with surgical staging if it is indicated.1 The National Compreh...
Eligibility Criteria
Inclusion
- \- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 20 2026
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05242276
Start Date
March 20 2022
End Date
March 20 2026
Last Update
October 10 2023
Active Locations (1)
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1
Hospital universitario y politécnico La Fe
Valencia, Spain, 46026