A Pilot Study on Training Simulator Efficacy

Not Applicable

Recruiting

• Conditions: Medical Education; Simulation Training; Laparoscopic Surgery
• Interventions: Other: LapSim training; Other: LapSim exam

• Registration Number: NCT05436899
• Lead Sponsor: Università degli Studi dell'Insubria

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.

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 Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Study Start: 2022-09-01
• Primary Completion: 2022-12-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-22
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive training group	LapSim training	Participants in this group will undergo an intensive virtual training program twice a week
Intensive training group	LapSim exam	Participants in this group will undergo an intensive virtual training program twice a week
Non-Intensive training group	LapSim training	Participants in this group will undergo a non-intensive virtual training program once a week
Non-Intensive training group	LapSim exam	Participants in this group will undergo a non-intensive virtual training program once a week

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Università degli Studi dell'Insubria; 🇮🇹 Varese, Italy