Evaluating the Use of Uterine Manipulator in Endometrial Cancer Surgery
A Prospective Study of the Impact of Uterine Manipulator on Oncological Outcome in Endometrial Cancer Surgery in Early-stage: Pro MUCEI Study
This study is testing whether using a uterine manipulator during surgery for early-stage endometrial cancer affects the chances of cancer coming back compared to surgery without it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Sex | Female |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Valencia) |
| Trial ID | NCT05242276 on ClinicalTrials.gov |
What this trial studies
This study aims to prospectively assess the impact of using a uterine manipulator during minimally invasive surgery for early-stage endometrial cancer. It seeks to confirm previous retrospective findings that suggested the use of this device may be associated with worse oncologic outcomes. The study will evaluate relapse rates in patients who underwent surgery with and without the manipulator, as well as identify risk factors that may contraindicate its use. The research is crucial for informing surgical practices and improving patient outcomes in endometrial cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with stage I-II endometrial cancer who have undergone a pre-surgical biopsy.
Not a fit: Patients with suspected disease beyond the uterus or those who underwent open surgery or conversion to laparotomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical practices and better oncologic outcomes for patients with early-stage endometrial cancer.
How similar studies have performed: While there have been retrospective studies indicating potential issues with the uterine manipulator, this prospective study aims to provide more definitive evidence, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Valencia
- Hospital universitario y politécnico La Fe — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Pablo Padilla iserte, MD, PhD — Hospital Universitario La Fe
- Study coordinator: Pablo Padilla iserte, MD, PhD
- Email: oncogine_lafe@gva.es
- Phone: 961244000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.