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OpenTrials
Completed

NCT Number: NCT00576043

Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

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.

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Key information

Conditions

Pain Behavior Health Behavior Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Satisfaction Signs and Symptoms Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Trainees: naive to real patient endoscopy before training phase

Exclusion criteria

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

Treatment and study plan

Simulator Training

Procedure

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

Primary outcomes

  1. Patient satisfaction measured on a visual analogue scale (VAS)

    Time frame: once immediately after patient endoscopy

Secondary outcomes

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

    Time frame: once immediately after patient endoscopy

  2. 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)

    Time frame: during endoscopy

  3. number of found/missed pathologies

    Time frame: during endoscopy

  4. average time for successful endoscopy

    Time frame: during endoscopy

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial

Acronym: endosim

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2007
Registry last updated
Mar 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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