Trial on Laparoscopic Simulation Based on Mentoring

Not Applicable

Completed

• Conditions: Performance of Wrong Procedure (Operation)
• Interventions: Other: Self-learning; Other: Mentoring

• Registration Number: NCT02486575
• Lead Sponsor: Università degli Studi di Brescia

Brief Summary

More than 50 residents in surgical specialities (OB\&G, General surgery and Urology) from a single university in Italy will be randomized into two groups, after a stratification based on residency year and laparoscopic/simulator experience. The first one will train to FLS (fundamentals of laparoscopic surgery) following pre-recorded instruction from course materials; the second one will be mentored by a proctor in single training section. The aim is to evaluate the best way to train residents applying for the very first time in an extensive way the "fundamentals of laparoscopic surgery" program in an Italian Institution.

Detailed Description

A complete 5-skills based FLS (fundamentals of laparoscopic surgery) curriculum is proposed to each resident enrolled in the trial. The first group trains with videos and written instructions, without any kind of support from a tutor. The second group is aided by a tutor, receiving tailored teaching and mentoring.

The primary goal was to asses the impact of tutoring in Passing the FLS examination at the end of a 3-months training: the outcome is the dichotomous PASS/DON'T PASS THE EXAM. At the same time the investigators assess the performance to record and evaluate any differences in groups and subgroups (year of residency, gender, specialty, etc.).

The evaluation was based on FLS program standards, recording time and penalties.

The training and evaluation setting was created to exactly reproduce the FLS one, mostly using the FLS material itself, or using FLS admitted/compatible instrumentation.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-24
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-30
• Last Update Submitted: 2015-06-30
• Study First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Residents in surgical specialities at University of Brescia

Exclusion Criteria

• Residents not available for the training (outside the Country, not interested, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
self-learning	Self-learning	Residents training alone with pre-recorded instructions. No tutor intervention, only self-learning training Intervention Type: Behavioral (video-based and instruction based learning)
Mentoring	Mentoring	Residents training with a mentor, giving tailored instruction to each of them and correction to wrong behaviours. Intervention Type: Behavioral (tutored learning)

Primary Outcome Measures

Name	Time	Method
Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES	2 months to compleete the training	2 months for the training and final evaluation in 2 weeks. Parameters evaluated during the final test are as defined by SAGES at "http://www.flsprogram.org" in the "manual skills" module.