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Trial on Laparoscopic Simulation Based on Mentoring

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02486575
Enrollment
60
Registered
2015-07-01
Start date
2014-01-31
Completion date
2014-06-30
Last updated
2015-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Performance of Wrong Procedure (Operation)

Keywords

Residents, Training, simulation, mentoring, proctor

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.

Interventions

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

OTHERMentoring

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

Sponsors

Università degli Studi di Brescia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Residents in surgical specialities at University of Brescia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES2 months to compleete the training2 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026