Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence

Sponsor
Egymedicalpedia (Industry)
Overall Status
Completed
CT.gov ID
NCT05540379
Collaborator
(none)
102
1
2
12
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Training
N/A

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Today it is generally accepted that the traditional apprentice-tutor model is no longer valid for training all skills necessary in Gynecological surgery and more specifically endoscopic surgery This agreement is based on the recognition that, in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

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
the efficacy of VR simulator training in improving basic gynecological hysteroscopic skillsthe efficacy of VR simulator training in improving basic gynecological hysteroscopic skills
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A: Ob/Gyn physicians

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

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

Active Comparator: Group B: Ob/Gyn physicians

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

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

Outcome Measures

Primary Outcome Measures

  1. Virtual Reality Training Score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
26 Years to 36 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine - Cairo University Giza Egypt

Sponsors and Collaborators

  • Egymedicalpedia

Investigators

  • Study Chair: Ahmed M Fawzi El-Minawi, Professor, Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University
  • Principal Investigator: Nadine A Sherif, Professor, Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Egymedicalpedia
ClinicalTrials.gov Identifier:
NCT05540379
Other Study ID Numbers:
  • Hagar Elnashar
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 14, 2022