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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06355596
Other study ID # 20IC6361
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2022
Est. completion date April 8, 2022

Study information

Verified date April 2024
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 8, 2022
Est. primary completion date April 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Adult (age > 18) - Medical student, Foundation Year or Core Trainee level or equivalent Exclusion Criteria: - Specialty Registrar level - Consultant level

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual teaching
Virtual teaching of laparoscopic skills

Locations

Country Name City State
United Kingdom St Mary's Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score Time to completion of task (minutes) Two days
Primary European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score Time to completion of task (minutes) Two days
Secondary SURG-TLX score Workload score ranging from 0 to 100 Two days
Secondary Heart rate Beats per minute Two days
Secondary Pupil metrics Mean pupil size (mm) and blinks per minute Two days
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