## Protocol Section
### Identification Module
**NCT ID:** NCT05540379

**Brief Title:** Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence

**Official Title:** Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence

#### Organization Study ID Info
**ID:** Hagar Elnashar
#### Organization
**Class:** INDUSTRY
**Full Name:** Egymedicalpedia
### Status Module
#### Completion Date
**Date:** 2022-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-14

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-05-01

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2022-09-14
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-09
**Study First Submit QC Date:** 2022-09-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Egymedicalpedia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Hysteroscopy

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** the efficacy of VR simulator training in improving basic gynecological hysteroscopic skills

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 102

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Virtual Reality Training

**Label:** Group A: Ob/Gyn physicians

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Device: Virtual Reality Training

**Label:** Group B: Ob/Gyn physicians

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A: Ob/Gyn physicians

- Group B: Ob/Gyn physicians

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

**Name:** Virtual Reality Training

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** • 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.

**Measure:** Virtual Reality Training Score

**Time Frame:** from baseline to 6 months after the trainig

### Eligibility Module

**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

**Maximum Age:** 36 Years

**Minimum Age:** 26 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Giza

**Country:** Egypt

**Facility:** Faculty of Medicine - Cairo University

#### Overall Officials

**Official 1:**

**Affiliation:** Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University

**Name:** Ahmed M Fawzi El-Minawi, Professor

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University

**Name:** Nadine A Sherif, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
