Developing a Curriculum to Teach Laparoscopic Colorectal Surgery

Education Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371136
• Other study ID #: SMH10-059
• Status: Completed
• Phase: N/A
• First received: June 8, 2011
• Last updated: November 16, 2015
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2015
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• resident in general surgery

• post graduate year (PGY) 2 or higher

• performed less than 10 laparoscopic colorectal procedures independently

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Education
• Laparoscopy
• Simulation
• Technical Skills Training

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Institutes of Health Research (CIHR), Royal College of Physicians and Surgeons of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in operating room performance between intervention and control group	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.	5 months from intervention	No
Secondary	Difference in cognitive knowledge between intervention and control group	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	5 months from the intervention	No
Secondary	Difference in technical performance on the virtual reality simulator between intervention and control group residents	Study participants will complete the easy level of the virtual reality training portion of the curriculum	5 months from intervention	No