- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06355596
Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W2 1NY
- St Mary's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult (age > 18)
- Medical student, Foundation Year or Core Trainee level or equivalent
Exclusion Criteria:
- Specialty Registrar level
- Consultant level
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Face-to-face teaching
Face-to-face teaching of laparoscopic skills
|
Virtual teaching of laparoscopic skills
|
|
Experimental: Virtual teaching
Virtual teaching of laparoscopic skills
|
Virtual teaching of laparoscopic skills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Two days
|
|
European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score
Time Frame: Two days
|
Time to completion of task (minutes)
|
Two days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SURG-TLX score
Time Frame: Two days
|
Workload score ranging from 0 to 100
|
Two days
|
|
Heart rate
Time Frame: Two days
|
Beats per minute
|
Two days
|
|
Pupil metrics
Time Frame: Two days
|
Mean pupil size (mm) and blinks per minute
|
Two days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20IC6361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.