How Effective Can a Simulator-Based Training Course For Beginners In Endoscopy Be Made? (EFFEKTRA)

June 27, 2023 updated by: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
The aim of the study is to clarify whether physicians training for gastroscopies benefit from a modified training course. The duration and type of optimized use of training simulators as part of a basic gastroscopy course can lead to a higher level of competence in patient examinations (main target parameters) than conventional use. Further goals are the comparison of the theoretical knowledge gained through the modified versus conventional course, as well as the self-assessment of the participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Training in interventional medicine, including surgery and endoscopy, is usually still done on the patient, under more or less qualified supervision. Previous exercises on models or simulators are still the exception and only reach around 40% of colleagues in countries with defined curricula and guidelines.The simulator-based training, however, offers a protected area in which, without risk to the patient, initial learning successes in flexible endoscopy can be achieved according to the "trial and error" principle. Various studies have shown that initial training on the simulator is beneficial: Physicians trained on the simulator require less support during the first examinations on the patient, less examination time, can reach and identify anatomical landmarks better and have better hand-eye coordination.If the simulator training is embedded in a structured curriculum, greater successes seem to be achieved in comparison to unstructured training. The feedback during the training is also a positive influencing factor; this should ideally take place at the end of each unit. It is also possible to use a simulator to train defined partial performances and to repeat these in the required amount. A step-by-step structure with defined intermediate goals, in the sense of mastery learning, also increases effectiveness.There is little data on the optimal duration or the saturation of the learning curve in simulator training. In one study the learning curve flattened after 60 simulated colonoscopies. Another study showed a gradual improvement up to 6 hours on the simulator. It also used threshold values for the performance score to define the optimal point in time for transition to patient-based training.

The current certification for the standardization of the nationwide endoscopy training courses by the German Gastroenterological Society (DGVS), provides for 4 hours of training on the simulator, including one hour of introduction. With an also recommended maximum group size of 4 participants per simulator, this corresponds to a duration of only 1 hour of effective simulator training per trainee. There are no recommendations for structuring simulator trainings or the type of simulators used.

The main aim of the present study is to find out whether it is possible to improve this situation without unrealistically extending the training and course times.

Trainees will randomly attend either a conventional training or an extended simulator training. Immediately after the course, in accordance with the DGVS guidelines, an examination of the same content for both groups to inquire the theoretical knowledge is done.1-5 weeks after completion of the training course, an evaluation of the endoscopic skills of the participants takes place. It is done on the patient, under supervision, as is currently customary in everyday clinical training. After a one-day introduction through observation of routine gastroscopies, two gastroscopies are then carried out. Two endoscopists independently assess the performance based on a Video record of the examination. All endoscopists involved in supervision or assessment are blinded to the trainee's group membership..

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Hospital Eppendorf
      • Hamburg, Germany, 22457
        • Albertinen Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

see above

Description

Inclusion Criteria:

Trainees:

  • licensed physicians in internal medicine, surgery or gastroenterology,
  • no endoscopic or laparoscopic experience
  • informed consent

Patient's endoscopies:

  • all patients > 18 years of age who are capable of being informed and have a clinical indication for esophagogastroduodenoscopy
  • informed consent
  • simple examination expected

Exclusion Criteria:

Patient's endoscopies:

- difficult examination expected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
conventional gastroscopy training course
physicians receive the DGVS-recommended training, consisting of a 2-day course with 1 hour of simulator training
Other: conventional DGVS training
see above
extended simulator course
physicians receive a two-day simulator course with a minimum of 6 hours of simulator training per trainee, structured in stages in the sense of progressive or mastery learning. The initial part of the training will be part-task training.
Other: extended simulator training
see above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score
Time Frame: one to five weeks after training course
Comparison of the GAGES competence score of the video-based observations of the first two patient examinations, each assessed by two endoscopists. To be valuated: intubation of esophagus, scope navigation, ability to keep a clear endoscope field, instrumentation, quality of examination. Best score each question 5 pts, worst 1 pt.
one to five weeks after training course
Non-inferiority of the new training procedure
Time Frame: through study completion, approximately 1 year
Non-inferiority of the new training procedure in the final exams according to DGVS criteria
through study completion, approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
competence assessment Direct Observation of Procedural Skills (DOPS) by Joint Advisory Group on Gastrointestinal Endoscopy (JAG)
Time Frame: one to five weeks after training course
Comparison of the JAG DOPS competence level of the video-based observations of the first two patient examinations, each assessed by two endoscopists. Assession of trainee's needed level of supervision at pre- and post procedure, insertion and withdrawal, visualisation, management of findings, and non-technical skills. Each has 4 values, best is "Competent for independent practice", worst is "maximal supervision"
one to five weeks after training course
Assessment of Competency in Endoscopy (ACE)
Time Frame: one to five weeks after training course
Comparison of the ACE competence evaluation of the video-based observations of the first two patient examinations, each assessed by two endoscopists.
one to five weeks after training course
mean self-assessment by Visual Analog Scale (VAS)
Time Frame: one to five weeks after training course
VAS after the first two patient examinations. This enables an assessment of the stress level and ultimately a measurement of the cognitive load of the subject. To be evaluated on a non-scaled line from "do not agree at all" to "totally agree".
one to five weeks after training course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Olympus Deutschland GmbH

Investigators

  • Principal Investigator: Thomas Rösch, Prof. Dr., Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PV7217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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