Clinical trial · Interventional
Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer
Feasibility, Safety, and Efficacy of Robotic Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer: A Pilot Study
- 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)
Patients with clinically confirmed endometrioid endometrial cancer at FIGO stage IA-IB were eligible for robotic single-port hysterectomy (R-SPH). Criteria included: well or moderately differentiated tumor grade (G1 or G2), sufficient vaginal access, uterine size under 12 weeks' gestation, adequate bone marrow, kidney, liver, and heart function, and an ECOG performance status of 2 or below. Exclusions applied to patients with significant cardiopulmonary disease, previous pelvic or abdominal radiation, or severe hip disease affecting positioning. Prior abdominal surgeries did not exclude patients from robotic surgery. Surgeries were performed using the Vinci Single-Site® system by a specialized team. Clinical data collected included age, BMI, FIGO stage, tumor grade, surgical margin status, and hospital stay duration. Operation times were divided into docking, console (surgical), and total operation times. Intraoperative assessments included complications, blood loss, hemoglobin changes, and transfusions if hemoglobin was ≤7 g/L. Postoperative complications were evaluated short- and long-term, including surgical, cardiac, and respiratory events.
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 |
|---|---|---|---|
| DaVinci SP | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Operative Time
- timeFrame
- during the intervention/procedure/surgery
- description
- duration of the hysterectomy, measured in minutes
- measure
- Docking Time
- timeFrame
- during the intervention/procedure/surgery
- description
- Duration of the davinci SP docking, measured in minutes
- measure
- Console Time
- timeFrame
- during the intervention/procedure/surgery
- description
- Time spent by the surgeon in the console during the surgical operation, measured in minutes
- measure
- Blood loss
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: Patients with clinically confirmed endometrioid endometrial cancer, FIGO stage IA-IB. \- Exclusion Criteria: significant cardiopulmonary disease or contraindications for prolonged Trendelenburg position; prior pelvic or abdominal radiotherapy; severe hip disease limiting dorsolithotomy position \-
References
Publications (10)
- RESULTClavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. PMID 19638912
- RESULTBarletta F, Corrado G, Vizza E. Laparoscopic radical hysterectomy with the use of SNAIL Tenaculum™. A simplified uterine manipulator for the management of early cervical cancer
- RESULTPecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet. 2009 May;105(2):103-4. doi: 10.1016/j.ijgo.2009.02.012. No abstract available. PMID 19367689
- RESULTNguyen TT, Basilius J, Ali SN, Dobbs RW, Lee DI. Single-Port Robotic Applications in Urology. J Endourol. 2023 Jun;37(6):688-699. doi: 10.1089/end.2022.0600. Epub 2023 May 15. PMID 37029799
- RESULTJung JM, Kim YI, Yoon YS, Yang S, Kim MH, Lee JL, Kim CW, Park IJ, Lim SB, Yu CS. Short-term outcomes of da Vinci SP versus Xi for colon cancer surgery: a propensity-score matching analysis of multicenter cohorts. J Robot Surg. 2023 Dec;17(6):2911-2917. doi: 10.1007/s11701-023-01727-3. Epub 2023 Oct 11. PMID 37821761
- RESULTArcieri, P. Romeo, G Vizzielli, S. Restaino, L. Driul, G. Stabile, R. Granese, S. Cianci, A. Ercoli. (2023). Robotic Single-Port da Vinci Surgical System (SP1098) in Gynecologic Surgery: A Systematic Review of Literature. Clinical and Experimental Obstetrics and Gynecology.
- RESULTCianci S, Rosati A, Rumolo V, Gueli Alletti S, Gallotta V, Turco LC, Corrado G, Vizzielli G, Fagotti A, Fanfani F, Scambia G, Uccella S. Robotic Single-Port Platform in General, Urologic, and Gynecologic Surgeries: A Systematic Review of the Literature and Meta-analysis. World J Surg. 2019 Oct;43(10):2401-2419. doi: 10.1007/s00268-019-05049-0.