Simulator Training for Gastrointestinal Endoscopy

NCT ID: NCT01405443

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Performance of Inappropriate Operation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Thomas Rösch

Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Rösch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Sabrie N, Khan R, Plahouras J, Johnston BC, Scaffidi MA, Grover SC, Walsh CM. Virtual reality simulation training for health professions trainees in gastrointestinal endoscopy. Cochrane Database Syst Rev. 2025 Sep 8;9(9):CD008237. doi: 10.1002/14651858.CD008237.pub4.

Reference Type DERIVED
PMID: 40919710 (View on PubMed)

Other Identifiers

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UKE Hamburg Endoscopy PV3656

Identifier Type: -

Identifier Source: org_study_id

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