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临床试验/NCT05540379
NCT05540379已完成不适用

Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年5月1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
102
试验地点
1
主要终点
Virtual Reality Training Score

研究概览

简要总结

Evaluation the efficacy of Virtual Reality simulator training in improving basic gynecological hysteroscopic skills and assess training levels in Ob/Gyn residents, as compared to others with previous hysteroscopic experience.

详细描述

Diagnostic or operative hysteroscopy is one of the most common surgical intervention in gynecological surgery. In recent years, it has acquired a central role in diagnosis and treatment of a variety of uterine pathologies like fibroids, polyps and uterine malformations It is also pivotal in the management of primary or secondary infertility. Biopsy specimens are also sampled with hysteroscopy in the diagnosis of endometrial cancer.

In recent years, the technological advancements such as the use of small diameter (3,5mm) rigid hysteroscopes combined with "no touch" techniques have made hysteroscopy a commonly accepted procedure .

As a minimally invasive procedure, hysteroscopy is associated with fewer complications than traditional open surgery However, it is challenging to gain manual dexterity in hysteroscopy because of the fulcrum effect and the orientation between the two-dimensional screen and the three-dimensional uterine cavity. Other difficulties are the diminished tactile feedback and limited degrees of freedom, . Lack of proficiency in hysteroscopy can compromise patient safety by causing uterine perforation and trauma to neighboring organs. Also, pulmonary air embolisms and pulmonary edema are potential life-threatening complications.

Today it is generally accepted that the traditional apprentice-tutor model is no longer valid for training all skills necessary in Gynecological surgery and more specifically endoscopic surgery This agreement is based on the recognition that, in contrast to open surgery, endoscopic surgery demands surgical skills and psychomotor skills that should not necessarily be trained simultaneously. Increasing evidence strongly suggests that psychomotor skills must be trained earlier and outside the operating room, and several models have been proposed for this aim

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
26 Years 至 36 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Residents, assistant lecturers, lecturers, associate professors and professors in Ob/Gyn department.
  • Group A: Ob/Gyn physicians who had performed less than 50 diagnostic hysteroscopies and hysteroscopic polypectomy.
  • Group B: Ob/Gyn physicians who had performed at least 50 diagnostic hysteroscopies and hysteroscopic polypectomy.

排除标准

  • 1- Physicians who had previously attended VR simulator training course

结局指标

主要结局

Virtual Reality Training Score

时间窗: from baseline to 6 months after the trainig

• To compare the final score achieved by the physicians who had performed less than 50 diagnostic hysteroscopies and hysteroscopic polypectomy after 3 training sessions on VR hysteroscopy simulator with the score achieved by physicians who had performed at least 50 diagnostic hysteroscopies and hysteroscopic polypectomy to ensure the role of VR in training for hysteroscopic polypectomy.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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