RecruitingNCT07027046

Application of da Vinci SP for Endometrial Cancer Surgical Staging

Application of da Vinci SP for Endometrial Cancer Surgical Staging: a Prospective Multicenter Study

Sponsor

National Cancer Institute, Naples

Enrollment

564 participants

Start Date

Apr 3, 2025

Study Type

OBSERVATIONAL

Conditions

Endometrial Cancer

Summary

Prospective Multicenter Observational Study The study involves the consecutive inclusion of every patient with endometrial cancer undergoing staging surgical treatment using a robotic approach with the da Vinci SP platform.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

Age ≥ 18 years
Histologically confirmed endometrial carcinoma (including uterine carcinosarcoma)
Performance status (ECOG) 0 - 1
Patients undergoing staging surgery for endometrial cancer, including but not limited to robotic hysterectomy with bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion) and possible sentinel lymph node biopsy/pelvic ± para-aortic lymphadenectomy
Signed informed consent to participate in the study

Exclusion Criteria6

Patients scheduled for an additional extra-genital surgical procedure during the staging surgery for endometrial carcinoma
Patients with anesthesiological contraindications to a minimally invasive approach
Synchronous tumor
Recurrence of endometrial carcinoma
Dementia or significantly altered mental status that may impair understanding and the ability to provide informed consent
Any reason that may interfere with regular follow-up, even if limited to the first 30 days post-surgery

Interventions

PROCEDURERobotic surgical staging

The intervention includes hysterectomy, bilateral salpingo-oophorectomy, and sentinel lymph node mapping, with possible lymphadenectomy or omentectomy, depending on histology.