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Clinical Trials in Italy / NCT07027046
Recruiting Observational

Application of da Vinci SP for Endometrial Cancer Surgical Staging

NCT07027046 · tracked via the Priya Life Science Italy tracker
Sponsor
National Cancer Institute, Naples
Phase
Observational
Started
2025-04-03
Last updated
2025-09-19

Condition(s) studied

Endometrial Cancer

Investigational drug(s) / intervention(s)

Robotic surgical staging

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

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Rate of satisfactory completion of staging surgery according to the criteria of national and international guidelines for the treatment of endometrial carcinoma. — 12 months
  • Rate of intraoperative complications, after categorization based on the type of complication and the timing of its occurrence. — 12 months
  • Rate of postoperative complications, after categorization based on the type of complication (within 30 days after surgery, after 30 days post-surgery) and according to the Clavien-Dindo classification. — 48 months

Trial sites (3)

FacilityCityRegionStatus
Istituto Nazionale Tumori | "Fondazione Pascale" Naples Napoli Recruiting
IEO - Istituto Europeo di Oncologia Milan Italy Recruiting
Istituti Fisioterapici Ospitalieri - IFO Roma Italy Recruiting

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Other trials for the same condition

Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer Recruiting
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer Recruiting
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) Recruiting
Advancing Risk Stratification in Endometrial Cancer Active, not recruiting
DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07027046 on ClinicalTrials.gov ↗ ← All trials in Italy