Pelvic vs Virtual Reality Simulator

NCT ID: NCT05255614

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-08-01

Brief Summary

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The aim of this study is to evaluate the proper sequence of Pelvic trainer and VR simulator training in order to improve gynecological laparoscopic skills and assess training levels.

Detailed Description

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In this study, the investigators will determine the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator in order to improve laparoscopic skills of residents with no or little previous laparoscopic experience.

* This study will compare the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator of two groups: Group A versus Group B.
* Group A will start training on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1). Then at a later time, they will be trained on VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2).
* Group B will start training on the VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2). Then at a later time, they will be trained on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1).

Conditions

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Laparoscopic Training

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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First Group

the participants will start training on the pelvic trainer and assessment will be via assessment via a checklist. Then at a later time, they will be trained on VR simulator (Sim Surgery) and assessment will be via Electronic auto assessment via the Simulator.

Group Type ACTIVE_COMPARATOR

Virtual reality Simulator

Intervention Type DEVICE

LapSim is a device designed by Surgical Science Device \& software at Swedan

Pelvic trainer:

Intervention Type DEVICE

Video-box trainers include a box with a lid and holes cut on the lid for the trocar's insertion. A laparoscope inside the box is connected with a digital camera and provides video output to a monitor on which the trainees are watching their own movements, while performing the teaching task. Laparoscopic instruments, such as laparoscopic graspers and laparoscopic scissors are inserted through the trocars into the box, where the tasks are taught

Second Group

the participants will start training on VR simulator (Sim Surgery) and assessment will be via Electronic auto assessment via the Simulator. Then at a later time, they will be trained on the pelvic trainer and assessment will be via assessment via a checklist.

Group Type ACTIVE_COMPARATOR

Virtual reality Simulator

Intervention Type DEVICE

LapSim is a device designed by Surgical Science Device \& software at Swedan

Pelvic trainer:

Intervention Type DEVICE

Video-box trainers include a box with a lid and holes cut on the lid for the trocar's insertion. A laparoscope inside the box is connected with a digital camera and provides video output to a monitor on which the trainees are watching their own movements, while performing the teaching task. Laparoscopic instruments, such as laparoscopic graspers and laparoscopic scissors are inserted through the trocars into the box, where the tasks are taught

Interventions

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Virtual reality Simulator

LapSim is a device designed by Surgical Science Device \& software at Swedan

Intervention Type DEVICE

Pelvic trainer:

Video-box trainers include a box with a lid and holes cut on the lid for the trocar's insertion. A laparoscope inside the box is connected with a digital camera and provides video output to a monitor on which the trainees are watching their own movements, while performing the teaching task. Laparoscopic instruments, such as laparoscopic graspers and laparoscopic scissors are inserted through the trocars into the box, where the tasks are taught

Intervention Type DEVICE

Other Intervention Names

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LapSim

Eligibility Criteria

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Inclusion Criteria

* All the residents in Obstetrics and Gynecology department who have no or little previous laparoscopic experience

Exclusion Criteria

* Residents who have previous good laparoscopic experiences.
* Age below 26 or Above 29 years
Minimum Eligible Age

26 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Abdalla

Clinical professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa M Abdalla, MD

Role: PRINCIPAL_INVESTIGATOR

Kasralainy teaching hospital

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Related Links

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https://pubmed.ncbi.nlm.nih.gov/17081183/

Virtual reality simulation training can improve technical skills during laparoscopic salpingectomy for ectopic pregnancy

https://pubmed.ncbi.nlm.nih.gov/10204564/

Assessment of technical skills transfer from the bench training model to the human model

https://pubmed.ncbi.nlm.nih.gov/18971133/

Description and validation of the Pelv-Sim: a training model designed to improve gynecologic minimally invasive suturing skills

Other Identifiers

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Pelvic trainer vs VRS

Identifier Type: -

Identifier Source: org_study_id

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