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OpenTrials
Completed

NCT Number: NCT02486575

Trial on Laparoscopic Simulation Based on Mentoring

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.

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Key information

Conditions

Performance of Wrong Procedure (Operation)

Age range

24 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residents in surgical specialities at University of Brescia

Exclusion criteria

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

Treatment and study plan

Self-learning

Other

Every resident will train following the video instruction included in the FLS course material and related written instruction only

Mentoring

Other

A tutor will follow each resident during learning, giving instruction, examples and any kind of suggestions.

Primary outcomes

  1. Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

Comparison of Laparoscopic Simulation Training Between Mentoring and Self-learning Technique

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 1, 2015
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.