Clinical trial NCT05540379: Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence
Official title: Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 102
Sex: ALL
Minimum age (years): 26
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the efficacy of VR simulator training in improving basic gynecological hysteroscopic skills
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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Today it is generally accepted that the traditional apprentice-tutor model is no longer valid for training all skills necessary in Gynecological surgery and more specifically endoscopic surgery This agreement is based on the recognition that, in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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1- Physicians who had previously attended VR simulator training course

Primary outcomes:
measure: Virtual Reality Training Score
timeFrame: from baseline to 6 months after the trainig
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Medicine - Cairo University
Study officials:
affiliation: Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University
name: Ahmed M Fawzi El-Minawi, Professor
role: STUDY_CHAIR
affiliation: Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University
name: Nadine A Sherif, Professor
role: PRINCIPAL_INVESTIGATOR
References: