NCT00576043

Brief Summary

Trainees (Residents in internal medicine), naive to real patient endoscopy, will be randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction and pain, technical accuracy and number of found/missed pathologies as well as average time for successful endoscopy will be recorded. After one month or 50 supervised, self performed endoscopies, trainees will be evaluated again with the above mentioned criteria during ten consecutive investigations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

Enrollment Period

4 years

First QC Date

December 17, 2007

Last Update Submit

March 25, 2008

Conditions

Pain

Keywords

trainingPatient satisfactionendoscopysimulatorSafety

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction measured on a visual analogue scale (VAS)

    once immediately after patient endoscopy

Secondary Outcomes (4)

  • pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS)

    once immediately after patient endoscopy

  • technical accuracy (oral introduction of the scope into the esophagus, ability of passing the endoscope through the pylorus, inversion of the scope in the gastric fundus)

    during endoscopy

  • number of found/missed pathologies

    during endoscopy

  • average time for successful endoscopy

    during endoscopy

Study Arms (2)

1: Training

ACTIVE COMPARATOR

3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator

Procedure: Simulator Training

2: No Training

NO INTERVENTION

No simulator training before starting endoscopy training on real patients

Interventions

Simulator TrainingPROCEDURE

3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator with the GI-Mentor Virtual simulator device

1: Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Trainees: naive to real patient endoscopy before training phase

You may not qualify if:

  • Medical doctors with experience in gastrointestinal endoscopy
  • Patients sedated for upper GI endoscopy
  • Patients unwilling or unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Ferlitsch A, Glauninger P, Gupper A, Schillinger M, Haefner M, Gangl A, Schoefl R. Evaluation of a virtual endoscopy simulator for training in gastrointestinal endoscopy. Endoscopy. 2002 Sep;34(9):698-702. doi: 10.1055/s-2002-33456.

    PMID: 12195326BACKGROUND

MeSH Terms

Conditions

PainPatient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Arnulf Ferlitsch, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

March 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

AU(1)