Simulator Training for Gastrointestinal Endoscopy
This study is currently recruiting participants.
Verified January 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01405443
First received: April 15, 2011
Last updated: January 21, 2013
Last verified: January 2013
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Purpose
This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training.
| Condition |
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Performance of Inappropriate Operation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Simulator Training for Gastrointestinal Endoscopy - How Much Simulator Training is Required to Acquire Proficiency in Gastrointestinal Endoscopy? |
Resource links provided by NLM:
Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:
Primary Outcome Measures:
- Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group one [ Time Frame: Score is evaluated after one week training ] [ Designated as safety issue: No ]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 [ Time Frame: Score is evaluated after three weeks of training ] [ Designated as safety issue: No ]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 [ Time Frame: Score is evaluated after two weeks of training ] [ Designated as safety issue: No ]Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.
Secondary Outcome Measures:
- Simulator score [ Time Frame: 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) ] [ Designated as safety issue: No ]Scores as evaluated by the Simbionix simulator software
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Basic training
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.
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Intermediate training
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.
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Extended training
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy
Criteria
Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405443
Contacts
| Contact: Daniel von Renteln, Dr. | +49 40 7410 50098 | renteln@gmx.net |
| Contact: Thomas Rösch, Prof. Dr. | +49 40 7410 51479 | t.roesch@uke.de |
Locations
| Germany | |
| Universitätsklinikum Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Thomas Roesch, Prof. Dr. +49 40 7410 50098 t.roesch@uke.de | |
| Contact: Daniel von Renteln, Dr. +49 40 7410 51479 renteln@gmx.net | |
| Principal Investigator: Daniel von Renteln, Dr. | |
| Sub-Investigator: Thomas Rösch, Prof. Dr. | |
| Sub-Investigator: Ulrike W. Denzer, PD Dr. | |
| Sub-Investigator: Guido Schachschal, Dr. | |
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
| Principal Investigator: | Thomas Rösch, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Thomas Rösch, Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department, Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT01405443 History of Changes |
| Other Study ID Numbers: | UKE Hamburg Endoscopy PV3656 |
| Study First Received: | April 15, 2011 |
| Last Updated: | January 21, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
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Simulator training Flexible endoscopy Gastrointestinal endoscopy |
Colonoscopy Training Performance |
ClinicalTrials.gov processed this record on June 18, 2013