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临床试验/NCT06681831
NCT06681831已完成不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Operative Time

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients with clinically confirmed endometrioid endometrial cancer, FIGO stage IA-IB.

排除标准

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

结局指标

主要结局

Operative Time

时间窗: during the intervention/procedure/surgery

duration of the hysterectomy, measured in minutes

Docking Time

时间窗: during the intervention/procedure/surgery

Duration of the davinci SP docking, measured in minutes

Console Time

时间窗: during the intervention/procedure/surgery

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

Blood loss

时间窗: during the intervention/procedure/surgery

Blood loss during the surgery, measured in ml

Change in hemoglobin

时间窗: immediately after the intervention/procedure/surgery

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Corrado Giacomo

Principal investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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