A Pilot Study on Training Simulator Efficacy

NCT ID: NCT05436899

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Laparoscopic Surgery Medical Education Simulation Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intensive training group

Participants in this group will undergo an intensive virtual training program twice a week

Group Type EXPERIMENTAL

LapSim training

Intervention Type OTHER

Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.

LapSim exam

Intervention Type OTHER

Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.

Non-Intensive training group

Participants in this group will undergo a non-intensive virtual training program once a week

Group Type ACTIVE_COMPARATOR

LapSim training

Intervention Type OTHER

Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.

LapSim exam

Intervention Type OTHER

Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.

Interventions

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LapSim training

Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.

Intervention Type OTHER

LapSim exam

Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Andrea Selenito Imperatori

Associate Professor of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Imperatori

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Locations

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Università degli Studi dell'Insubria

Varese, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Imperatori

Role: CONTACT

+39-0332-393195

Facility Contacts

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Andrea S Imperatori

Role: primary

+39-0332-393195

Other Identifiers

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LapSim training program

Identifier Type: -

Identifier Source: org_study_id

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