Developing a Curriculum to Teach Laparoscopic Colorectal Surgery

Study Overview
=================
Brief 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.

Conditions
-----------------
Education, Simulation, Technical Skills Training, Laparoscopy

Intervention / Treatment
-----------------
* Procedure: curricular training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resident in general surgery post graduate year (PGY) 2 or higher performed less than 10 laparoscopic colorectal procedures independently
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curricular Trained<br>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<br>* 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.<br>|
| No Intervention: conventional residency training<br>These residents proceed through surgical residency training as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |