Assessing the Efficacy of Enhanced Versus Standard 3D Training Models in Laparoscopic Skills Acquisition: A Randomised Controlled Trial

NCT06184854 | Completed

• 1 other identifier: QMERC22.110
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to compare the effect of using 3D-enhanced versus standard 3D (three-dimensional) training models when novice medical students practise certain laparoscopic tasks. The main question our trial aims to answer is:

• Are the 3D-enhanced training models used superior compared to the existing standard 3D LapPass training models for laparoscopic skills learning in novice medical students? Participants will be assigned in one of the 2 groups and practise laparoscopic tasks in 2 separate sessions.

Conditions

Laparoscopic Skills Acquisition

Keywords

3D-enhanced training models; Standard 3D training models; laparoscopic skills; randomised controlled trial

Outcome Measures

Primary Outcomes (3)

• GOALS score ranging from 5 to 25

  The GOALS tool serves as a technique-specific method to assess the technical performance of novice medical students, with extensive evidence in the literature. GOALS tool is comprised of 5 domains: (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling and (5) autonomy scored with a 5-points scale for each domain according to the level of technical skills demonstrated with the total score ranging from 5-25.

  Baseline assessment after 20 minutes of task and equipment familiarisation (A1), Interim assessment at 1-hour of training and Post-training assessment at 2-hours of training (A3)

• Task completion time in minutes

  Completion time is defined as 'time to task completion with start time being the moment instruments are in view on the monitor and end time being the moment the task is completed with instruments removed or reaching the time limit of 10 minutes''.

  Baseline assessment after 20 minutes of task and equipment familiarisation (A1), Interim assessment at 1-hour of training and Post-training assessment at 2-hours of training (A3)

• Number of Erros

  Errors for the polo task are defined as '' dropping a polo'' and intracorporeal suturing task as ''poor approximation, insecure knot, incomplete knot or slipping knot''

  Baseline assessment after 20 minutes of task and equipment familiarisation (A1), Interim assessment at 1-hour of training and Post-training assessment at 2-hours of training (A3)

Secondary Outcomes (1)

• Post-study survey questions on participant perceived pre- and post-training confidence and overall performance with a Likert scale of 1-5

  Immediately after study completion (average 1 week from enrolment)

Study Arms (2)

Standard 3D LapPass Training Models

ACTIVE COMPARATOR

Participants in the standard 3D group practised laparoscopic skills using the standard 3D LapPass training models for polo manipulation and intracorporeal suturing

Other: Standard 3D LapPass Training Models

3D-Enhanced Training Models

EXPERIMENTAL

Participants in the 3D-enhanced group practised laparoscopic skills using the 3D-enhanced training models for polo manipulation and intracorporeal suturing

Other: 3D-Enhanced Training Models

Interventions

3D-Enhanced Training Models OTHER

3D-enhanced Jenga polo model for task 1 and 3D-enhanced suturing model for task 2

3D-Enhanced Training Models

Standard 3D LapPass Training Models OTHER

Standard 3D LapPass polo model for task 1 and standard 3D LapPass model for task 2

Standard 3D LapPass Training Models

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Medical students from Year 1 to Year 5 including intercalating students
• (2) Novices in laparoscopic surgery defined as having no formal laparoscopic skills training beyond camera navigation

You may not qualify if:

• (1) Undertaken at least one session of laparoscopic skills training
• (2) Uncommitted to the completion of the study

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Cancer Institute, Queen Mary University of London

London, EC1M 6BE, United Kingdom

Location

Related Publications (1)

• Alampritis G, Rossou C, Patel B. Assessing the Efficacy of Enhanced Versus Standard Three-Dimensional Training Models in Laparoscopic Skills Acquisition: A Randomized Controlled Trial of Novice Medical Students. J Surg Educ. 2024 Dec;81(12):103278. doi: 10.1016/j.jsurg.2024.08.028. Epub 2024 Oct 11.

  PMID: 39393177 DERIVED

Study Officials

• Georgios Alampritis

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 28, 2023
• Study Start: May 18, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Anonymised participant data will be retained for a period of at least 10 years from the date of any publication which is based upon it, as specified in the QMUL Records Retention schedule. After this period all data will be destroyed.
• Access Criteria: On request

Locations

GB (1)