Clinical trial NCT06681831: Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: davinci sp
endometrial cancer
robotic surgery
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria: Patients with clinically confirmed endometrioid endometrial cancer, FIGO stage IA-IB.

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Exclusion Criteria: significant cardiopulmonary disease or contraindications for prolonged Trendelenburg position; prior pelvic or abdominal radiotherapy; severe hip disease limiting dorsolithotomy position

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Primary outcomes:
measure: Operative Time
timeFrame: during the intervention/procedure/surgery
measure: Docking Time
timeFrame: during the intervention/procedure/surgery
measure: Console Time
timeFrame: during the intervention/procedure/surgery
measure: Blood loss
timeFrame: during the intervention/procedure/surgery
measure: Change in hemoglobin
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS regina elena cancer istitute
Study officials:
References:
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