A Pilot Study on Training Simulator Efficacy

NCT05436899 | Unknown

• 1 other identifier: LapSim training program
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Surgery; Medical Education; Simulation Training

Keywords

Education; Simulation; Virtual reality; Laparoscopic surgery; Learning curve; Endoscopic surgery; Thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intensive vs non-intensive training group

  48 weeks

Study Arms (2)

Intensive training group

EXPERIMENTAL

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

Other: LapSim training; Other: LapSim exam

Non-Intensive training group

ACTIVE COMPARATOR

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

Other: LapSim training; Other: LapSim exam

Interventions

LapSim training OTHER

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

Intensive training group; Non-Intensive training group

LapSim exam OTHER

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

Intensive training group; Non-Intensive training group

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Università degli Studi dell'Insubria

Varese, 21100, Italy

RECRUITING

Study Officials

• Andrea Imperatori

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Imperatori

CONTACT

+39-0332-393195; andrea.imperatori@uninsubria.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Thoracic Surgery

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2025
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Proposals should be directed to andrea.imperatori@uninsubria.it

Locations

IT (1)