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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05255614
Other study ID # Pelvic trainer vs VRS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date August 1, 2022

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 26 Years to 29 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual reality Simulator
LapSim is a device designed by Surgical Science Device & software at Swedan
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

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary assessment of time needed to accomplish the tests before and after pelvic trainer assessment of time needed to accomplish the tests before and after pelvic trainer 6 months
Primary assessment of time needed to accomplish the tests before and after victual reality simulator assessment of time needed to accomplish the tests before and after victual reality simulator 6 months
See also
  Status Clinical Trial Phase
Completed NCT03407235 - Simulating Laparoscopy With an Eye Patch N/A