NCT06355596

Brief 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.

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 surgery

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable surgery

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

Study Start

First participant enrolled

March 11, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

28 days

First QC Date

March 19, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

Laparoscopic surgery skillsMedical educationMinimally invasive surgery

Outcome Measures

Primary Outcomes (2)

  • McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score

    Time to completion of task (minutes)

    Two days

  • European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score

    Time to completion of task (minutes)

    Two days

Secondary Outcomes (3)

  • SURG-TLX score

    Two days

  • Heart rate

    Two days

  • Pupil metrics

    Two days

Study Arms (2)

Face-to-face teaching

ACTIVE COMPARATOR

Face-to-face teaching of laparoscopic skills

Other: Virtual teaching

Virtual teaching

EXPERIMENTAL

Virtual teaching of laparoscopic skills

Other: Virtual teaching

Interventions

Virtual teaching of laparoscopic skills

Face-to-face teachingVirtual teaching

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (age \> 18)
  • Medical student, Foundation Year or Core Trainee level or equivalent

You may not qualify if:

  • Specialty Registrar level
  • Consultant level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Participants are randomly allocated to either face-to-face or virtual teaching groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

April 9, 2024

Study Start

March 11, 2022

Primary Completion

April 8, 2022

Study Completion

April 8, 2022

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations