Clinical trial · Observational
Application of da Vinci SP for Endometrial Cancer Surgical Staging
Application of da Vinci SP for Endometrial Cancer Surgical Staging: a Prospective Multicenter Study
NCT07027046CI-TRIAL-00095419recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic surgical staging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Da Vinci SP Surgical Staging Group
- description
- Patients with early-stage endometrial cancer undergoing robotic surgical staging using the Da Vinci SP system.
- interventionNames
- Procedure: Robotic surgical staging
Primary outcomes (3)
- measure
- Rate of satisfactory completion of staging surgery according to the criteria of national and international guidelines for the treatment of endometrial carcinoma.
- timeFrame
- 12 months
- measure
- Rate of intraoperative complications, after categorization based on the type of complication and the timing of its occurrence.
- timeFrame
- 12 months
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.