Trial on Laparoscopic Simulation Based on Mentoring

NCT02486575 | Completed

• 1 other identifier: TUTOR LAP SYM
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Performance of Wrong Procedure (Operation)

Keywords

Residents; Training; simulation; mentoring; proctor

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

self-learning

OTHER

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

Mentoring

OTHER

Residents training with a mentor, giving tailored instruction to each of them and correction to wrong behaviours. Intervention Type: Behavioral (tutored learning)

Other: Mentoring

Interventions

Self-learning OTHER

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

self-learning

Mentoring OTHER

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

Mentoring

Eligibility Criteria

• Age: 24 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents in surgical specialities at University of Brescia

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Related Publications (1)

• 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.

  PMID: 29644465 DERIVED

Study Officials

• Nazario Portolani, MD

  Università degli Studi di Brescia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research specialist

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: July 1, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 1, 2015

Record last verified: 2015-06