Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence

NCT ID: NCT05540379

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-04-30

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Today it is generally accepted that the traditional apprentice-tutor model is no longer valid for training all skills necessary in Gynecological surgery and more specifically endoscopic surgery This agreement is based on the recognition that, in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

Conditions

Hysteroscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group A: Ob/Gyn physicians

It is about 51 participants whom had performed less than 50 diagnostic hysteroscopies and hysteroscopic polypectomy.

Group Type: ACTIVE_COMPARATOR

Virtual Reality Training

Intervention Type: DEVICE

Training the obstetrics and Gynecologist Residents on Virtual endoscopic simulation and skills acquisition

Group B: Ob/Gyn physicians

It is about 51 participants whom had performed at least 50 diagnostic hysteroscopies and hysteroscopic polypectomy.

Group Type: ACTIVE_COMPARATOR

Virtual Reality Training

Intervention Type: DEVICE

Training the obstetrics and Gynecologist Residents on Virtual endoscopic simulation and skills acquisition

Interventions

Virtual Reality Training

Training the obstetrics and Gynecologist Residents on Virtual endoscopic simulation and skills acquisition

Intervention Type: DEVICE

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

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Fawzi El-Minawi, Professor

Role: STUDY_CHAIR

Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University

Nadine A Sherif, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University

Locations

Faculty of Medicine - Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

Hagar Elnashar

Identifier Type: -

Identifier Source: org_study_id