Simulator Training for Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training.

Detailed Description
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Randomized controlled trial evaluating different training intervals on an endoscopy simulator and comparing performance using a validated score (Global assessment of Gastrointestinal Endoscopic Skills). Physicians participating in the study are novices with no previous experience in flexible endoscopy. Subjects are randomized into three different training arms. Proficiency scores will be evaluated by a supervising physician blinded to group allocation.

Official Title
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Simulator Training for Gastrointestinal Endoscopy - How Much Simulator Training is Required to Acquire Proficiency in Gastrointestinal Endoscopy?

Conditions
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Performance of Inappropriate Operation

Participation Criteria
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Eligibility Criteria
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Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic training<br>Theory lecture esophagogastroduodenoscopy (EGD). One hour simulator training for EGD. 30 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. One hour simulator training for Colonoscopy. 30 minutes supervised training. Supervised endoscopy. Group will be followed up for 2 weeks training time. | |
| Intermediate training<br>Theory lecture EGD. Three hours simulator training for EGD. 60 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Three hours simulator training for Colonoscopy. 60 minutes supervised training. Supervised endoscopy. Group will be followed up for 4 weeks training time. | |
| Extended training<br>Theory lecture EGD. Five hours simulator training for EGD. 90 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Five hours simulator training for Colonoscopy. 90 minutes supervised training. Supervised endoscopy. Group will be followed up for 6 weeks training time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated proficiency score (GAGES Global assessment for Gastrointestinal Endoscopy) for group one | Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation. | Score is evaluated after one week training | 
| Validated proficiency score (GAGES Global assessment for Gastrointestinal Endoscopy) for group three | Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation. | Score is evaluated after three weeks of training | 
| Validated proficiency score (GAGES Global assessment for Gastrointestinal Endoscopy) for group two | Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation. | Score is evaluated after two weeks of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulator score | Scores as evaluated by the Simbionix simulator software | Score is evaluated after the training period (at one week for group 1, at 2 weeks for group 2, and at three weeks for group 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simulator training, Flexible endoscopy, Gastrointestinal endoscopy, Colonoscopy, Training, Performance