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Endometrial CancerNCT06681831

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

A study testing DaVinci SP in people with Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
DaVinci SP
Type of treatment
Medical device
How many people
15 participants
Where
1 siteItaly
Study dates
26 Jun 2024to 15 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

-

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS regina elena cancer istitute

    Rome, Rome, 00128

Other trials in Italy

About this study

Official title: 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

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.

Read the detailed description

Patients with clinically confirmed endometrioid endometrial cancer, International Federation of Gynaecology and Obstetrics stage IA-IB were eligible for R-SPH. Other eligibility criteria included: tumor grades well (G1) or moderately differentiated (G2) at biopsy; adequate vaginal access and uterine size < 12 weeks gestation; adequate bone marrow reserve (absolute granulocyte count ≥2000/ml, platelet count ≥100000/ml); and adequate renal, hepatic, and cardiac function; ECOG performance status of 2 or less.

Patients were excluded from RSSH if they had any of the following: significant cardiopulmonary disease or contraindications for prolonged Trendelenburg position; prior pelvic or abdominal radiotherapy; severe hip disease limiting dorsolithotomy position. Previous abdominal surgery did not disqualify patients from the robotic approach.

Informed consent, including clinical evaluation and robotic single-port surgery, was obtained from all patients in accordance with local and international legislation (Declaration of Helsinki). All cases were performed on Vinci Single-Site® surgical system (Intuitive Surgical Inc®, 1266 Kifer Road, Building 101 Sunnyvale, CA) and the surgical team consisted of the primary surgeon (E.V.), bedside assistant and a robotics-dedicated scrub technician and circulating nurse.

Clinical patient characteristics included age, body mass index (BMI), clinical stage according to FIGO, and tumor grade. Moreover, status of the surgical margins and length of hospitalization, were evaluated. The time of the operation was subdivided into: (1) docking time, the time from the moment of port placement until the second robotic arm is mounted to the corresponding cannula; (2) console time, the actual surgical time, measured from the moment the surgeon starts maneuvering the surgical instruments until he orders their retrieval; and (3) operation time, the total skin-to-skin time. Intraoperative parameters included complications, blood loss, and hemoglobin levels before and 24 hours post-surgery. Blood transfusions were administered if hemoglobin was ≤ 7 g/L. Postoperative complications were assessed both short-term (within 30 days) and long-term (beyond 30 days), focusing on surgical, cardiac, pulmonary, and other events.

Pain was evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (agonizing pain) at several intervals post-surgery. Analgesics included continuous infusion of tramadol and ketorolac for the first 24 hours, with paracetamol available on request. The cosmetic results of the umbilical scar were assessed by both patients and surgeons on days 1 and 30 post-surgery, with satisfaction rated from 0 (poor) to 10 (excellent).

Surgical procedure:

After indocyanine intracervical injection we used swabs to buffer the vagina. The cervix was closed and no uterus manipulator devices were used, but the cervix was closed with a modified tenaculum called "simple nebs arising incision landmark" (SNAIL®).

The first step started with an initial access, with an 2,5 cm long incision made over the lower rim of the umbilicus down to the level of the fascia, which was opened along the longitudinal axis of the body.

The leading edge of the folded port was inserted into the incision with a downward motion while countertraction was provided by retractors within the incision. An Intuitive Access Port of small size is placed into the incision and pneumoperitoneum is established by insufflating the abdomen to a pressure of 12 mm Hg. Patients were then placed in the steep Trendelenburg, low-lithotomy position, and the Da Vinci SP robot was docked laterally to the patients on the left side.

The Intuitive Access Port has four different channel port: in the superior channel was inserted a three-dimension 8.5mm optics,in channel number 1 was inserted a Cadiere Forceps, in channel number 2 a Maryland Bipolar and in channel number 3 a Monopolar Scissors (MCS). All instruments, including the camera, are articulating.

A careful inspection of the entire abdominal cavity was performed to identify any suspicious peritoneal lesion that would exclude the patient from having the procedure completed by robotic SP: the inspection is performed by inserting only the optics into the port. Afterward, all other instruments are introduced, and we proceeded with the surgical operation. After resection of the round ligament and an incision of the retroperitoneum over the course of the iliac external vessels, the ureter was visualized, a window was opened between the ovarian pedicle above and the ureter below, and ovarian pedicles were coagulated with Maryland Bipolar and resected with MCS. Next, we developed the retroperitoneal spaces (paravesical space, Lasko fossa, medial pararectal fossa, or Okabayashi pararectal space) from the right side to the left, identified the sentinel node on each side using Firefly, and removed it. Afterward, a type A hysterectomy was performed as described by Querleu and Morrow and uterine vessels were coagulated with Maryland Bipolar and resected with MCS. Colpotomy was performed with the MCS. The uterus and the adnexa were extracted through the vagina and sent for frozen section analysis. The vaginal vault was closed with a continuous suture using V-Loc and a needle driver instead of MCS. Finally, according to the frozen section results, we performed the systematic lymphadenectomy: following the guidelines, we performed lymphadenectomy only in patients with intermediate or high risk.

The arrangement of the instruments is the same as for hysterectomy. Lymphadenectomy is divided in three steps:

  • First step: the surgeon prepares the medial limit of the lymphadenectomy starting from the common iliac artery following the hypogastric artery and the obliterated umbilical artery.
  • Second step: the lateral limit is prepared by detaching pelvic vessels from the muscular surface of the pelvis
  • Third step: the periadventitial plate of the common iliac artery and the external iliac artery is incised in a centrifugal direction and the lymph nodes are removed "en bloc" up to the obturator nerve. The lymph nodes are insert in an endobag and removed through the vaginal canal before the vagina is sutured.
Being tested
DaVinci SP
Keywords
davinci sp, endometrial cancer, robotic surgery
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaVinci SPDevice

    Also called robotic singleport surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative Time

    duration of the hysterectomy, measured in minutes

    Measured: during the intervention/procedure/surgery

  2. Docking Time

    Duration of the davinci SP docking, measured in minutes

    Measured: during the intervention/procedure/surgery

  3. Console Time

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

    Measured: during the intervention/procedure/surgery

  4. Blood loss

    Blood loss during the surgery, measured in ml

    Measured: during the intervention/procedure/surgery

  5. Change in hemoglobin

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

    Measured: immediately after the intervention/procedure/surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start26 Jun 2024
  3. Primary completion1 Oct 2024
  4. Study completion15 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681831
Sponsor's protocol ID
864/16
Status last verified
Nov 2024
First submitted
4 Nov 2024
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19638912
  • 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

  • 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.

    PubMed 19367689
  • 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.

    PubMed 37029799
  • 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.

    PubMed 37821761
  • 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.

  • 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.

    PubMed 31187247
  • 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.

    PubMed 29040189
  • 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.

    PubMed 35962708
  • 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.

    PubMed 40788153

Questions about this trial

What is this clinical trial studying?

A study testing DaVinci SP in people with Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative Time (time frame: during the intervention/procedure/surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06681831, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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