Design and Validation of a Simulation-based Training Curriculum for Laparoscopic Bariatric Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01610466|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : November 17, 2015
|Condition or disease||Intervention/treatment|
|Obesity||Procedure: Laparoscopic bariatric surgery ex-vivo training curriculum|
OBJECTIVE: To design and validate a proficiency-based ex-vivo training curriculum for laparoscopic bariatric surgery.
BACKGROUND: 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, specific simulation-based training curricula have not been widely adopted in residency training programs. This is likely a result of the lack of valid simulation-based training curricula for minimally invasive operations. Presently, there is no evidence-based ex-vivo training curriculum for laparoscopic bariatric surgery. The purpose of this project is to develop and validate such a curriculum.
HYPOTHESIS: Completion of the proposed training curriculum is expected to result in superior cognitive knowledge, superior technical skills in the operating room, and superior performance in a simulated crisis scenario when compared to standard residency training.
METHODS: The evidence-based training curriculum will be made up of cognitive, technical, and non-technical components. The cognitive component will deliver procedure-specific knowledge, while the technical component will provide training in basic and procedure-specific laparoscopic skills. Non-technical component will address additional components of surgical competency including situation awareness, decision making, task management, leadership, communication and teamwork. Technical skills will be learned on a bench-top cadaveric porcine models. Training will follow a distributed practice schedule until preset proficiency benchmarks are achieved. The proposed training curriculum will be validated in a single-blinded randomized controlled trial comparing procedure-specific knowledge, technical performance in the operating room, and non-technical skills in a simulated crisis scenario for 12 surgical residents in the curricular training group and 12 residents in the standard residency training group. Cognitive knowledge will be assessed with a multiple choice examination. Technical performance will be assessed with previously validated procedure-specific and global rating scales. Non-technical skills will be assessed using a previously validated NOTECHS scale.
CONCLUSIONS: The design and implementation of the proposed training curriculum has the potential to affect surgical training programs on a national and international level by standardizing the proficiency of surgical trainees prior to the start of operating room training. This standardization is expected to shorten the learning curves and improve patient safety in the operating room.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Design and Validation of a Simulation-based Training Curriculum for Laparoscopic Bariatric Surgery|
|Study Start Date :||July 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Experimental: Curriculum training group
Surgical residents in the curriculum training group will complete the entire curriculum. They will participate in a cognitive component, which will consist of self-directed readings and a faculty-led seminar. Participants will also train to proficiency in laparoscopic jejunojejunostomy and gastrojejunostomy using a laparoscopic box trainer with cadaveric porcine bowels. Finally, for the non-technical skills component participants will participate in an introductory lecture on non-technical skills in surgery, as well as a practice crisis scenario with a debriefing session.
Procedure: Laparoscopic bariatric surgery ex-vivo training curriculum
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.
No Intervention: Conventional training group
Participants in the conventional training group will proceed through surgical residency training in the usual fashion.
- Difference in operating room performance between curriculum trained and conventionally trained groups [ Time Frame: 5 months ]Surgical residents participating in the study will perform a laparoscopic jejunojejunostomy in the operating room. The procedure will be video-recorded through the laparoscopic camera. The videos will be given to a blinded and trained rater who will assess the technical proficiency of the resident using a validated rating scale.
- Difference in cognitive knowledge between curriculum trained and conventionally trained groups [ Time Frame: 5 months ]Surgical residents in both groups will complete a multiple choice test designed to assess their knowledge in regards to the laparoscopic bariatric surgery.
- Difference in non-technical skills between curriculum trained and conventionally trained groups [ Time Frame: 5 months ]Surgical residents will participate in a simulated operating room crisis scenario. Their performance will be video recorded and assessed by a trained rater using a validated rating scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610466
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Teodor P Grantcharov, MD, PhD||St. Michael's Hospital, Toronto|