A Pilot Study on Training Simulator Efficacy

August 20, 2023 updated by: Andrea Selenito Imperatori, Università degli Studi dell'Insubria

Training Simulator Efficacy in Developing Thoracic and General Surgical Skills in an Academic Residency Program: a Pilot Study

The purpose of this study is to plan an effective learning path in minimally invasive thoracic and general surgery with a virtual training simulator for trainees and to assess the improvement of residents' surgical skills by the introduction of this virtual training program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All thoracic and general surgery trainees at the first and second year of residency will be randomized in two groups: A) trainees undergoing an intensive (twice a week) virtual training program and B) those undergoing a non-intensive virtual training program (once a week).

The virtual training program will be organized in 4 modules, each of 12 weeks and, according to the training simulator instructions, for each surgical skill there are predetermined goals to be achieved by the trainee. Data about duration of surgical maneuvers and type and number of mistakes made by the trainee at each training session will be collected and compared with those of the same trainee at the previous session; this will assess the number of training sessions required to achieve the training simulator predetermined goals. Moreover, the same data will be registered at the beginning and at the end of each courses to compare the two groups of trainees (intensive vs non-intensive program).

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Trainees at the first and second year of residency in thoracic or general surgery

Exclusion Criteria:

  • Fully trained surgeons
  • Persons who are not trainees at year of specialization higher than the second

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive training group
Participants in this group will undergo an intensive virtual training program twice a week
Other: LapSim training
Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.
Other: LapSim exam
Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.
Active Comparator: Non-Intensive training group
Participants in this group will undergo a non-intensive virtual training program once a week
Other: LapSim training
Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.
Other: LapSim exam
Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning curves of time, errors and economy of motion for each training tasks
Time Frame: 48 weeks
For each task, the computer automatically measures set parameters. Time, errors and economy of motion will be used in data analysis to create the learning curves for both intensive and non-intensive training group.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive vs non-intensive training group
Time Frame: 48 weeks
For each exam tasks of the four training courses, compare the difference between the intensive and non-intensive training group, before and after each program training. Time, errors and economy of motion will be used in data analysis.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Principal Investigator: Andrea Imperatori, Università degli Studi dell'Insubria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 20, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LapSim training program

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data that underlie the results reported in this article (text, tables, figures, and appendices)

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Proposals should be directed to andrea.imperatori@uninsubria.it

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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