CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Laparoscopic bariatric surgery ex-vivo training curriculumprocedure
Likely dose
Not stated in record
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Search/NCT01610466
NCT01610466N/ACompleted

Design and Validation of a Simulation-based Training Curriculum for Laparoscopic Bariatric Surgery

Unity Health Toronto·interventional·Posted Jun 4, 2012·Updated Nov 17, 2015

In Brief

A clinical study evaluating Laparoscopic bariatric surgery ex-vivo training curriculum for Obesity. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Laparoscopic bariatric surgery is an advanced laparoscopic procedure with a potential for significant morbidity and mortality along the early part of a surgeon's learning curve. Simulation-based training has been shown to improve a surgeon's technical performance and shorten the learning curves in the operating room. Despite these benefits, there is no evidence-based ex-vivo training curriculum for laparoscopic bariatric surgery. The purpose of this study is to design and validate such a curriculum. This curriculum will include cognitive training, technical laparoscopic skills training (laparoscopic gastrojejunostomy and jejunojejunostomy) and non-technical skills training in a simulated environment. The investigators will assess the effectiveness of the proposed curriculum by conducting a randomized single blinded controlled trial. Cognitive knowledge (multiple choice test), technical skills (performance of a procedure in the operating room) and non-technical skills (performance in a simulated crisis scenario in a simulated environment) will be compared between curriculum trained and conventionally trained groups. The investigators hypothesize that curriculum trained group will have superior knowledge, technical skill and non-technical skills compared to conventionally trained group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesCanada

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2012
Enrollment StartJul 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.1 years ago

Interventions

Laparoscopic bariatric surgery ex-vivo training curriculumprocedure

The training curriculum will consist of a cognitive, technical and non-technical components. Cognitive component will consist of self-directed readings and a faculty-led seminar. Technical component will consist of training to proficiency on cadaveric porcine laparoscopic jejunojejunostomy and gastrojejunostomy models. Non-technical component will consist of an introductory lecture on non-technical skills in surgery and a simulated crisis scenario with a debriefing session.