Trial on Laparoscopic Simulation Based on Mentoring

June 30, 2015 updated by: Federico Gheza, Università degli Studi di Brescia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Other: Self-learning
Every resident will train following the video instruction included in the FLS course material and related written instruction only
Other: Mentoring

Residents training with a mentor, giving tailored instruction to each of them and correction to wrong behaviours.

Intervention Type: Behavioral (tutored learning)
Other: Mentoring
A tutor will follow each resident during learning, giving instruction, examples and any kind of suggestions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months to compleete the training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Investigators

  • Study Director: Nazario Portolani, MD, Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TUTOR LAP SYM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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