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临床试验/NCT06278636
NCT06278636招募中不适用

Laparoscopic Ultrasound Examination: Analysis of Feasibility and fEllows Surgeons' LEarning Curve in Minimally Invasive Gynecological Procedures

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
feasibility of the laparoscopic

研究概览

简要总结

This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery.

The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon.

详细描述

The use of laparoscopic ultrasound is an evolving field with a potentially wide range of advantages that could facilitate complex gynecologic surgical procedures; increasing surgical safety by allowing the surgeon to see beyond the surface of the organ, visualizing anatomical structures and identifying, for example, retroperitoneal recurrences and benign or malignant pelvic lesions, even small and not visible laparoscopically, and consequently improving the surgical accuracy of tumor resection. (10) Gynecologists who are familiar with gynecological transvaginal ultrasound should be able to become proficient in identifying pelvic organs during surgical procedures in order to improve surgical accuracy, reduce complications, and ultimately improve patient care.

Nevertheless, this technique has been slow to be implemented in the clinical setting, perhaps due to the lack of a learning curve. Therefore, training gynecological surgical fellows in recognizing pelvic structures using laparoscopic probes is critical for allows them to use this tool in different application fields, providing them with an important advantage. The training of gynecological surgeons in the use of laparoscopic probes would provide an advantage in terms of surgical time, speeding up the procedures of recognition and removal of target lesions. In addition, by making surgeons autonomous in the operating theatre, the need for an additional ultrasound operator during surgery would be eliminated. These benefits would translate into a potential reduction in cost as well

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Fellow surgeons with EFSUMB level 1 experience of ultrasound in gynecology.
  • Women affected by gynecological pathologies undergoing elective laparoscopic surgery such as endometrial cancer, cervical cancer at early stage, or benign pathologies.
  • All women will be required to sign written informed consent to enter the study.

排除标准

  • Patients affected by gynaecological pathologies undergoing emergency surgeries.
  • Refusal to sign written informed consent.
  • Patients with previous hysterectomy or salpingo-oophorectomy.
  • Uterus and adnexa not visualised at LPS examination.

结局指标

主要结局

feasibility of the laparoscopic

时间窗: 2 minutes

for to assess the feasibility of the laparoscopic ultrasound examination during minimally invasive gynaecological surgery, achievement of one ultrasound picture in maximum 120 seconds examination during minimally invasive gynaecological surgery, in terms of achievement of one ultrasound picture in maximum 120 seconds

次要结局

  • the performance of fellow surgeons(30 minutes)
  • the learning curve of fellow surgeons(5 minutes)

研究者

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

Mascilini Floriana

Ph.D

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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