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

NCT01610466 | Completed

• 1 other identifier: SMH 11-202
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Education; Simulation; Technical skills training; Laparoscopy; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Difference in operating room performance between curriculum trained and conventionally trained groups

  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.

  5 months

Secondary Outcomes (2)

• Difference in cognitive knowledge between curriculum trained and conventionally trained groups

  5 months

• Difference in non-technical skills between curriculum trained and conventionally trained groups

  5 months

Study Arms (2)

Curriculum training group

EXPERIMENTAL

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

Conventional training group

NO INTERVENTION

Participants in the conventional training group will proceed through surgical residency training in the usual fashion.

Interventions

Laparoscopic bariatric surgery ex-vivo training curriculum PROCEDURE

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.

Curriculum training group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Royal College of Physicians and Surgeons of Canada: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (8)

• Zevin B, Aggarwal R, Grantcharov TP. Simulation-based training and learning curves in laparoscopic Roux-en-Y gastric bypass. Br J Surg. 2012 Jul;99(7):887-95. doi: 10.1002/bjs.8748. Epub 2012 Apr 18.

  PMID: 22511220 BACKGROUND

• Rehrig ST, Powers K, Jones DB. Integrating simulation in surgery as a teaching tool and credentialing standard. J Gastrointest Surg. 2008 Feb;12(2):222-33. doi: 10.1007/s11605-007-0250-8. Epub 2007 Nov 15.

  PMID: 18004630 BACKGROUND

• Aggarwal R, Grantcharov TP, Darzi A. Framework for systematic training and assessment of technical skills. J Am Coll Surg. 2007 Apr;204(4):697-705. doi: 10.1016/j.jamcollsurg.2007.01.016. No abstract available.

  PMID: 17382230 BACKGROUND

• Fried GM, Feldman LS, Vassiliou MC, Fraser SA, Stanbridge D, Ghitulescu G, Andrew CG. Proving the value of simulation in laparoscopic surgery. Ann Surg. 2004 Sep;240(3):518-25; discussion 525-8. doi: 10.1097/01.sla.0000136941.46529.56.

  PMID: 15319723 BACKGROUND

• Aggarwal R, Boza C, Hance J, Leong J, Lacy A, Darzi A. Skills acquisition for laparoscopic gastric bypass in the training laboratory: an innovative approach. Obes Surg. 2007 Jan;17(1):19-27. doi: 10.1007/s11695-007-9001-x.

  PMID: 17355764 BACKGROUND

• Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8.

  PMID: 18362635 BACKGROUND

• Sevdalis N, Davis R, Koutantji M, Undre S, Darzi A, Vincent CA. Reliability of a revised NOTECHS scale for use in surgical teams. Am J Surg. 2008 Aug;196(2):184-90. doi: 10.1016/j.amjsurg.2007.08.070. Epub 2008 Jun 16.

  PMID: 18558392 BACKGROUND

• Korndorffer JR Jr, Dunne JB, Sierra R, Stefanidis D, Touchard CL, Scott DJ. Simulator training for laparoscopic suturing using performance goals translates to the operating room. J Am Coll Surg. 2005 Jul;201(1):23-9. doi: 10.1016/j.jamcollsurg.2005.02.021.

  PMID: 15978440 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Teodor P Grantcharov, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Surgery

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 4, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

CA (1)