A Pilot Study on Training Simulator Efficacy

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436899
• Other study ID #: LapSim training program
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Università degli Studi dell'Insubria
• Contact: Andrea Imperatori
• Phone: +39-0332-393195
• Email: andrea.imperatori[@]uninsubria.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Surgery
• Medical Education
• Simulation Training

Intervention

Other:
• LapSim training
Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.
• LapSim exam
Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.

Locations

Country	Name	City	State
Italy	Università degli Studi dell'Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Learning curves of time, errors and economy of motion for each training tasks	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	Intensive vs non-intensive training group	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