Single‑incision da Vinci SP robotic surgical staging for endometrial cancer
Official title: Application of da Vinci SP for Endometrial Cancer Surgical Staging: a Prospective Multicenter Study
Run by National Cancer Institute, Naples · NCT07027046 · Data updated 2026-11-12
This study will try using the da Vinci SP single‑port robotic system to perform surgical staging in adults with endometrial cancer to see how it works and how patients recover.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 564 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 3 sites (Naples, Napoli and 2 other locations) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | June 2026 |
| Study ends | June 2029 |
| Registry record updated | September 19, 2025 |
| Trial ID | NCT07027046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically confirmed endometrial carcinoma who are medically fit for minimally invasive surgery (ECOG 0–1) and scheduled for robotic surgical staging who can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with recurrent or synchronous tumors, those requiring additional extra‑genital procedures, those with anesthetic contraindications to minimally invasive surgery, or those unable to complete regular follow‑up are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational project that will consecutively enroll patients with endometrial cancer who undergo robotic staging using the da Vinci SP platform. Procedures include hysterectomy with bilateral salpingo‑oophorectomy (with ovarian preservation allowed in selected cases) and possible sentinel lymph node biopsy or pelvic/para‑aortic lymphadenectomy as clinically indicated. The study will record perioperative metrics such as operative time, blood loss, conversion rates, complications, and early oncologic and recovery outcomes. No experimental treatment is assigned; data will be collected to document feasibility, safety, and early performance of the single‑port robotic approach.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive single‑incision option that may reduce pain, shorten recovery time, and improve cosmetic outcomes compared with multiport techniques.
How similar studies have gone: Multiport laparoscopic and robotic approaches have established safety and outcomes in endometrial cancer, while single‑port robotic platforms like da Vinci SP are newer and have shown promising but still limited feasibility data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, Napoli, Italy Recruiting -
IEO - Istituto Europeo di Oncologia
Milan, Italy Recruiting -
Istituti Fisioterapici Ospitalieri - IFO
Roma, Italy Recruiting
Study contacts
- Principal investigator: Vito Chiantera, MD — IRCCS I.N.T. "G. Pascale"
- Study coordinator: Giuseppe Cucinella, MD
- Email: giuseppe.cucinella@istitutotumori.na.it
- Phone: 00000000000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.