SurgeryNCT06355596
Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills
A study testing Virtual teaching in people with Surgery, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Virtual teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2022to 8 Apr 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (age > 18)
- Medical student, Foundation Year or Core Trainee level or equivalent
Who cannot join
- Specialty Registrar level
- Consultant level
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:
Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?
Read more
Participants in this study will:
Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.
Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks.
- Conditions
- Surgery
- Being tested
- Virtual teaching
- Keywords
- Laparoscopic surgery skills, Medical education, Minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual teachingOther
Virtual teaching of laparoscopic skills
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face teaching | Active comparator | Face-to-face teaching of laparoscopic skills Receives: Other: Virtual teaching |
| Virtual teaching | Experimental | Virtual teaching of laparoscopic skills Receives: Other: Virtual teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score
Time to completion of task (minutes)
Measured: Two days
European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score
Time to completion of task (minutes)
Measured: Two days
Secondary outcomes (3)
SURG-TLX score
Workload score ranging from 0 to 100
Measured: Two days
Heart rate
Beats per minute
Measured: Two days
Pupil metrics
Mean pupil size (mm) and blinks per minute
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start11 Mar 2022
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants are randomly allocated to either face-to-face or virtual teaching groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355596
- Sponsor's protocol ID
- 20IC6361
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills
- ClinicalTrials.gov ID
- NCT06355596
- Acronym / sponsor ID
- 20IC6361
- Conditions
- Surgery
- Keywords
- Laparoscopic surgery skills, Medical education, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 9 Apr 2024 (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 goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:
Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?
Participants in this study will:
Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.
Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated to either face-to-face or virtual teaching groups
| Arm | Type | Receives |
|---|---|---|
| Face-to-face teaching | Active comparator | Other: Virtual teachingFace-to-face teaching of laparoscopic skills |
| Virtual teaching | Experimental | Other: Virtual teachingVirtual teaching of laparoscopic skills |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (age > 18)
- Medical student, Foundation Year or Core Trainee level or equivalent
Key exclusion criteria (2 listed)
- Specialty Registrar level
- Consultant level
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 teachingVirtual teaching of laparoscopic skills | Other | Face-to-face teaching, Virtual teaching |
Primary outcome
McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score
Time frame: Two days
Time to completion of task (minutes)
European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score
Time frame: Two days
Time to completion of task (minutes)
3 secondary outcomes
SURG-TLX score
Time frame: Two days
Heart rate
Time frame: Two days
Pupil metrics
Time frame: Two days
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 9 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Surgery
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 teaching in people with Surgery, run by Imperial College London at 1 site in United Kingdom.
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 2 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 9 Apr 2024. 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 United Kingdom. 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?
McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score (time frame: Two days). 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 9 Apr 2024.