Simulator Training for Gastrointestinal Endoscopy

Terminated

• Conditions: Performance of Inappropriate Operation

• Registration Number: NCT01405443
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Simulator score	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)	Scores as evaluated by the Simbionix simulator software

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany