Simulator Training for Gastrointestinal Endoscopy

Performance of Inappropriate Operation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01405443
• Other study ID #: UKE Hamburg Endoscopy PV3656
• Status: Terminated
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Performance of Inappropriate Operation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)