A Pilot Study on Training Simulator Efficacy

Sponsor
Università degli Studi dell'Insubria (Other)
Overall Status
Recruiting
CT.gov ID
NCT05436899
Collaborator
(none)
36
1
2
40
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: LapSim training
  • Other: LapSim exam
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Training Simulator Efficacy in Developing Thoracic and General Surgical Skills in an Academic Residency Program: a Pilot Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Learning curves of time, errors and economy of motion for each training tasks [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.

Secondary Outcome Measures

  1. Intensive vs non-intensive training group [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Università degli Studi dell'Insubria Varese Italy 21100

Sponsors and Collaborators

  • Università degli Studi dell'Insubria

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Selenito Imperatori, Associate Professor of Thoracic Surgery, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT05436899
Other Study ID Numbers:
  • LapSim training program
First Posted:
Jun 29, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrea Selenito Imperatori, Associate Professor of Thoracic Surgery, Università degli Studi dell'Insubria

Study Results

No Results Posted as of Jul 18, 2022