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Completed

NCT Number: NCT01371136

Developing a Curriculum to Teach Laparoscopic Colorectal Surgery

Although a significant amount of work has been done to validate simulators as viable systems to teach technical skills outside the operating room, the next necessary step is to integrate simulator training into a comprehensive curriculum. The purpose of this study is to develop and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery. This curriculum will include training on a virtual reality simulator, cognitive training and cadaver lab training. The investigators will assess the effectiveness of the curriculum by conducting a randomized single blinded controlled trial. The investigators will be comparing the technical performance of curricular trained and non-trained residents in the operating room, during a procedure on a patient. The investigators hypothesize that surgical residents who participate in the curriculum will have superior technical proficiency and cognitive knowledge relating to performing laparoscopic colorectal surgery compared to conventionally trained residents.

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Key information

Conditions

Education Laparoscopy Simulation Technical Skills Training

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5R3C3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • resident in general surgery
  • post graduate year (PGY) 2 or higher
  • performed less than 10 laparoscopic colorectal procedures independently

Treatment and study plan

curricular training

Procedure

Residents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an "easy", "medium" and "hard" level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver.

Primary outcomes

  1. Difference in operating room performance between intervention and control group

    Time frame: 5 months from intervention

    Surgical residents participating in the study will perform a laparoscopic right colectomy in the operating room. The procedure will be video-recorded through the laparoscopic camera. The videos will be given to a blinded expert in video assessment who will assess the technical proficiency of the resident using a validated global rating scale.

Secondary outcomes

  1. Difference in cognitive knowledge between intervention and control group

    Time frame: 5 months from the intervention

    Residents in both groups will complete a multiple choice test designed to assess the amount of cognitive knowledge they have relating to the technical steps of performing laparoscopic colorectal surgery

  2. Difference in technical performance on the virtual reality simulator between intervention and control group residents

    Time frame: 5 months from intervention

    Study participants will complete the easy level of the virtual reality training portion of the curriculum

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Royal College of Physicians and Surgeons of Canada

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2011
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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