Trial on Laparoscopic Simulation Based on Mentoring

NCT ID: NCT02486575

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Performance of Wrong Procedure (Operation)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Self-learning

Intervention Type: OTHER

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

Mentoring

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

Intervention Type: Behavioral (tutored learning)

Group Type: OTHER

Mentoring

Intervention Type: OTHER

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

Interventions

Self-learning

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

Intervention Type: OTHER

Mentoring

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Residents in surgical specialities at University of Brescia

Exclusion Criteria

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Federico Gheza

Research specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nazario Portolani, MD

Role: STUDY_DIRECTOR

Università degli Studi di Brescia

References

Gheza F, Raimondi P, Solaini L, Coccolini F, Baiocchi GL, Portolani N, Tiberio GAM. Impact of one-to-one tutoring on fundamentals of laparoscopic surgery (FLS) passing rate in a single center experience outside the United States: a randomized controlled trial. Surg Endosc. 2018 Nov;32(11):4428-4435. doi: 10.1007/s00464-018-6185-1. Epub 2018 Apr 11.

Reference Type: DERIVED

PMID: 29644465 (View on PubMed)

Other Identifiers

TUTOR LAP SYM

Identifier Type: -

Identifier Source: org_study_id