Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices

Study Overview
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Brief Summary
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This prospective randomized study aims for determination whether focused simulator based laparoscopic camera training in novices can improve camera performance in an actual clinical situations in the same manner as traditional training in the OR does, especially considering efficient use of training time.

Detailed Description
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Medical students in their final years without any significant experience in handling an angled laparoscopic camera participate in the study and perform a camera guidance test in surgery. The participants are then randomized in two groups to receive either a simulator based or traditional in theatre training during three weeks. The camera test will be repeated, while both tests are going to be recorded. Videos of 14 camera tests carried out by laparoscopic experts are taped as well.

Conditions
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Laparoscopy, Clinical Competence

Intervention / Treatment
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* Behavioral: Training on laparoscopic simulator in skills lab
* Behavioral: Training at actual laparoscopic surgery
* Behavioral: Technical instruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical students on a surgical clerkship rotation at the department of visceral and transplantation surgery of the university hospital of Zurich, Switzerland Exclusion Criteria: Any experience in laparoscopic camera handling in the OR and/or simulator based laparoscopic training
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operating room training<br> | Behavioral: Training at actual laparoscopic surgery<br>* Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks<br>Behavioral: Technical instruction<br>* Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour<br>|
| Active Comparator: Skills lab training<br> | Behavioral: Training on laparoscopic simulator in skills lab<br>* Laparoscopic camera training in a skills lab following training protocol for a total of 6 hours during 3 weeks.<br>Behavioral: Technical instruction<br>* Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress of skills shown in test regarding target centring as assessed by rating scale | Students are sent to the OR to do two camera assessment tests involving a standardized set of tasks they had to accomplish operation. They had to center and hold for 5 seconds the following positions/organs and had to maintain the correct horizontal alignment during camera movement: 1. Left abdominal wall, 2. Descending colon, 3. Right lobe of liver, 4. Sigmoid colon 5. Caecum 6. Pelvis 7. Trocar entry site in the upper left quadrant 8. Desc. Colon. This assessment was video-taped. A rating scale quantifying target centring was used. | After 3 weeks of individual training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time effort spend for respective training time | Total time effort for OR group was defined as time used from receiving pager call (to go to OR) to leaving OR. Time effort for Skillslab group was defined as total time spend in Skillslab. | During 3 weeks of individual training | 
| Progress of time to completion of test |  | After 3 weeks of individual training | 
| Progress of skills shown in test regarding horizon alignment as assessed by rating scale | Students are sent to the OR to do two camera assessment tests involving a standardized set of tasks they had to accomplish operation. They had to center and hold for 5 seconds the following positions/organs and had to maintain the correct horizontal alignment during camera movement: 1. Left abdominal wall, 2. Descending colon, 3. Right lobe of liver, 4. Sigmoid colon 5. Caecum 6. Pelvis 7. Trocar entry site in the upper left quadrant 8. Desc. Colon. This assessment was video-taped. A rating scale quantifying horizon alignment was used. | After 3 weeks of individual training |