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

This study is currently recruiting participants.
Verified December 2012 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Royal College of Physicians and Surgeons of Canada
Information provided by (Responsible Party):
Teodor Grantcharov, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01610466
First received: May 30, 2012
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Obesity
Procedure: Laparoscopic bariatric surgery ex-vivo training curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Design and Validation of a Simulation-based Training Curriculum for Laparoscopic Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Difference in operating room performance between curriculum trained and conventionally trained groups [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Difference in cognitive knowledge between curriculum trained and conventionally trained groups [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resident in general surgery at the University of Toronto
  • Post - graduate year (PGY) 3 or 4
  • Performed less than 10 laparoscopic bariatric operations independently

Exclusion Criteria:

  • Residents in other surgical programs at University of Toronto
  • Residents in general surgery at the University of Toronto in PGY1, 2, 5 or attending surgeons
  • Residents who have performed great than 10 laparoscopic bariatric operations independently
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610466

Contacts
Contact: Teodor P Grantcharov, MD, PhD 416-864-5748 grantcharovt@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Teodor P Grantcharov, MD, PhD    416-864-5748    grantcharovt@smh.ca   
Principal Investigator: Teodor P Grantcharov, MD, PhD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Royal College of Physicians and Surgeons of Canada
Investigators
Principal Investigator: Teodor P Grantcharov, MD, PhD St. Michael's Hospital, Toronto
  More Information

Publications:
Responsible Party: Teodor Grantcharov, Associate Professor, Department of Surgery, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01610466     History of Changes
Other Study ID Numbers: SMH 11-202
Study First Received: May 30, 2012
Last Updated: December 27, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Education
Simulation
Technical skills training
Laparoscopy
Bariatric Surgery

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014