Developing a Curriculum to Teach Laparoscopic Colorectal Surgery

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Royal College of Physicians and Surgeons of Canada
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01371136
First received: June 8, 2011
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Education
Simulation
Technical Skills Training
Laparoscopy
Procedure: curricular training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)

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

Primary Outcome Measures:
  • Difference in operating room performance between intervention and control group [ Time Frame: 5 months from intervention ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Difference in cognitive knowledge between intervention and control group [ Time Frame: 5 months from the intervention ] [ Designated as safety issue: No ]
    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

  • Difference in technical performance on the virtual reality simulator between intervention and control group residents [ Time Frame: 5 months from intervention ] [ Designated as safety issue: No ]
    Study participants will complete the easy level of the virtual reality training portion of the curriculum


Enrollment: 25
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curricular Trained
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.
Procedure: curricular training
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.
No Intervention: conventional residency training
These residents proceed through surgical residency training as usual

  Eligibility

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

Inclusion Criteria:

  • resident in general surgery
  • post graduate year (PGY) 2 or higher
  • performed less than 10 laparoscopic colorectal procedures independently
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371136

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5R3C3
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Royal College of Physicians and Surgeons of Canada
Investigators
Principal Investigator: Teodor P Grantcharov, MD, PhD St. Michael's Hospital, Toronto
  More Information

No publications provided by St. Michael's Hospital, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teodor Grantcharov, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT01371136     History of Changes
Other Study ID Numbers: SMH10-059
Study First Received: June 8, 2011
Last Updated: June 9, 2011
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 18, 2014