NCT05255614

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

January 19, 2022

Last Update Submit

August 25, 2023

Conditions

Keywords

Simulation trainingPelvic trainerVirtual reality Simulator

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

First Group

ACTIVE COMPARATOR

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.

Device: Virtual reality SimulatorDevice: Pelvic trainer:

Second Group

ACTIVE COMPARATOR

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.

Device: Virtual reality SimulatorDevice: Pelvic trainer:

Interventions

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

Also known as: LapSim
First GroupSecond Group

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

First GroupSecond Group

Eligibility Criteria

Age26 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Residents who have previous good laparoscopic experiences.
  • Age below 26 or Above 29 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

Related Links

Study Officials

  • Marwa M Abdalla, MD

    Kasralainy teaching hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 24, 2022

Study Start

February 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations