跳至主要内容
临床试验/NCT04898803
NCT04898803
已完成
不适用

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

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 32 人2020年8月3日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Physicians Gastroscopy Training
发起方
Universitätsklinikum Hamburg-Eppendorf
入组人数
32
试验地点
2
主要终点
Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score
状态
已完成
最后更新
2年前

概览

简要总结

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.

详细描述

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..

注册库
clinicaltrials.gov
开始日期
2020年8月3日
结束日期
2022年12月14日
最后更新
2年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Prof. Dr. Thomas Rösch

Clinical Director, Department of Interdisciplinary Endoscopy

Universitätsklinikum Hamburg-Eppendorf

入排标准

入选标准

  • 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

排除标准

  • Patient's endoscopies:
  • difficult examination expected

结局指标

主要结局

Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score

时间窗: 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.

Non-inferiority of the new training procedure

时间窗: through study completion, approximately 1 year

Non-inferiority of the new training procedure in the final exams according to DGVS criteria

次要结局

  • competence assessment Direct Observation of Procedural Skills (DOPS) by Joint Advisory Group on Gastrointestinal Endoscopy (JAG)(one to five weeks after training course)
  • Assessment of Competency in Endoscopy (ACE)(one to five weeks after training course)
  • mean self-assessment by Visual Analog Scale (VAS)(one to five weeks after training course)

研究点 (2)

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