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

November 16, 2015 updated by: Teodor Grantcharov, Unity Health Toronto
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Royal College of Physicians and Surgeons of Canada

Investigators

  • Principal Investigator: Teodor P Grantcharov, MD, PhD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMH 11-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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