Single‑incision da Vinci SP robotic surgical staging for endometrial cancer

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

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
• Enrollment: 564 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: National Cancer Institute, Naples (Academic / other)
• Locations: 3 sites (Naples, Napoli and 2 other locations)
• Trial ID: NCT07027046 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Naples, Napoli and 2 other locations

• 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

Conditions Endometrial Cancer