Laparoscopic TrainingNCT05255614
Pelvic vs Virtual Reality Simulator
A study testing Virtual reality Simulator and Pelvic trainer: in people with Laparoscopic Training, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 26 to 29 years
- Conditions the study is for
- Laparoscopic Training
- What is being tested?
- Virtual reality Simulator and Pelvic trainer:
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All the residents in Obstetrics and Gynecology department who have no or little previous laparoscopic experience
Who cannot join
- Residents who have previous good laparoscopic experiences.
- Age below 26 or Above 29 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study to Determine Proper Sequence of Simulation Training Pelvic Versus Virtual Reality Simulator
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.
Read the detailed 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).
- Conditions
- Laparoscopic Training
- Being tested
- Virtual reality Simulator, Pelvic trainer:
- Keywords
- Simulation training, Pelvic trainer, Virtual reality Simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality SimulatorDevice
Also called LapSim
LapSim is a device designed by Surgical Science Device \& software at Swedan
Pelvic trainer: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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual reality Simulator; Device: 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. Receives: Device: Virtual reality Simulator; Device: Pelvic trainer: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Feb 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic TrainingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Abdalla, Cairo University
- Investigators
- Marwa M Abdalla, MD, Principal investigator, Kasralainy teaching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255614
- Sponsor's protocol ID
- Pelvic trainer vs VRS
- Status last verified
- Aug 2023
- First submitted
- 19 Jan 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study to Determine Proper Sequence of Simulation Training Pelvic Versus Virtual Reality Simulator
- ClinicalTrials.gov ID
- NCT05255614
- Acronym / sponsor ID
- Pelvic trainer vs VRS
- Conditions
- Laparoscopic Training
- Keywords
- Simulation training, Pelvic trainer, Virtual reality Simulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Group | Active comparator | Device: Virtual reality Simulator, Device: Pelvic trainer: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. |
| Second Group | Active comparator | Device: Virtual reality Simulator, Device: Pelvic trainer: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. |
Who may qualify
- Ages
- 26 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All the residents in Obstetrics and Gynecology department who have no or little previous laparoscopic experience
Key exclusion criteria (2 listed)
- Residents who have previous good laparoscopic experiences.
- Age below 26 or Above 29 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality SimulatorAlso: LapSimLapSim is a device designed by Surgical Science Device \& software at Swedan | Device | First Group, Second Group |
| 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 | Device | First Group, Second Group |
Primary outcome
assessment of time needed to accomplish the tests before and after pelvic trainer
Time frame: 6 months
assessment of time needed to accomplish the tests before and after pelvic trainer
assessment of time needed to accomplish the tests before and after victual reality simulator
Time frame: 6 months
assessment of time needed to accomplish the tests before and after victual reality simulator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Virtual reality simulation training can improve technical skills during laparoscopic salpingectomy for ectopic pregnancyLink provided by the sponsor.
- Assessment of technical skills transfer from the bench training model to the human modelLink provided by the sponsor.
- Description and validation of the Pelv-Sim: a training model designed to improve gynecologic minimally invasive suturing skillsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa M Abdalla, MD principal investigator
Kasralainy teaching hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality Simulator and Pelvic trainer: in people with Laparoscopic Training, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of time needed to accomplish the tests before and after pelvic trainer (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.