Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer

NCT06681831 | Completed FDA Device

• 1 other identifier: 864/16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Endometrial Cancer

Keywords

davinci sp; endometrial cancer; robotic surgery

Outcome Measures

Primary Outcomes (5)

• Operative Time

  duration of the hysterectomy, measured in minutes

  during the intervention/procedure/surgery

• Docking Time

  Duration of the davinci SP docking, measured in minutes

  during the intervention/procedure/surgery

• Console Time

  Time spent by the surgeon in the console during the surgical operation, measured in minutes

  during the intervention/procedure/surgery

• Blood loss

  Blood loss during the surgery, measured in ml

  during the intervention/procedure/surgery

• Change in hemoglobin

  Change in hemoglobin after the surgery, measured in g/dl

  immediately after the intervention/procedure/surgery

Interventions

DaVinci SP DEVICE

robotic single-port hysterectomy (R-SPH) with DaVinci SP

Also known as: robotic singleport surgery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS regina elena cancer istitute

Rome, rome, 00128, Italy

Location

Related Publications (10)

• Clavien 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 BACKGROUND

• Barletta 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

  BACKGROUND

• Pecorelli 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 BACKGROUND

• Nguyen 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 BACKGROUND

• Jung 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 BACKGROUND

• Arcieri, 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.

  BACKGROUND

• Cianci 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.

  PMID: 31187247 BACKGROUND

• Corrado G, Calagna G, Cutillo G, Insinga S, Mancini E, Baiocco E, Zampa A, Bufalo A, Perino A, Vizza E. The Patient and Observer Scar Assessment Scale to Evaluate the Cosmetic Outcomes of the Robotic Single-Site Hysterectomy in Endometrial Cancer. Int J Gynecol Cancer. 2018 Jan;28(1):194-199. doi: 10.1097/IGC.0000000000001130.

  PMID: 29040189 BACKGROUND

• Bianco FM, Dreifuss NH, Chang B, Schlottmann F, Cubisino A, Mangano A, Pavelko Y, Masrur MA, Giulianotti PC. Robotic single-port surgery: Preliminary experience in general surgery. Int J Med Robot. 2022 Dec;18(6):e2453. doi: 10.1002/rcs.2453. Epub 2022 Aug 19.

  PMID: 35962708 BACKGROUND

• Vizza R, Corrado G, Mancini E, Baiocco E, Russo M, Vincenzoni C, Bruno V, Falconer H, Vizza E. 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. Minim Invasive Ther Allied Technol. 2025 Dec;34(6):433-440. doi: 10.1080/13645706.2025.2538764. Epub 2025 Aug 11.

  PMID: 40788153 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 8, 2024
• Study Start: June 26, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 15, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

IT (1)