Biomedical subjects

A Naegel

Publications and source records attributed to A Naegel.

6 recordsLinked to original sources

PubMed2006

The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial.

BACKGROUND: The objective benefit of a training using the compact Erlangen Active Simulator for Interventional Endoscopy-simulator was demonstrated in two prospective educational trials (New York, France). The present study analysed whether endoscopic novices are able to reach a comparable level of endoscopic skills as in the above-described projects. METHODS: Twenty-seven endoscopic novices (medical students, first year residents) were enrolled in this prospective, randomised trial. The compact Erlangen Active Simulator for Interventional Endoscopy-simulator with an upper GI-organ package and blood perfusion system was used as a training tool. Basic evaluation of endoscopic skills was performed after a practical and theoretical course in diagnostic upper GI endoscopy followed by a stratified randomisation according to the rating in endoscopic skills into intensive (n=14) and control group (n=13). The intensive group was trained 12 times every second week over 7 months in 4 endoscopic disciplines (manual skills, injection therapy, haemoclip, band ligation) by skilled endoscopist (three trainees/simulator). Assessment was performed (single steps/overall) using an analogue scale from 1 to 10 (1=worst, 10=optimal performance) by expert tutors. The control group was not trained. Blinded final evaluation of all participants was performed in January 2003. RESULTS: We observed in all techniques applied a significant improvement of endoscopic skills and of the performance time in the intensive group compared to the control group (p<0.001). The comparison with the previous projects showed that the intensively trained novices achieved comparable levels of performance to the GI fellows in the New York and France Project (at least 80% of the median score in three out of four techniques). CONCLUSION: Endoscopic novices acquired notable skills in interventional endoscopy in the simulator by an intensive, periodical training using the compactEASIE.

Clinical Competence↗

PubMed2006

"Hemodynamic efficacy" of two endoscopic clip devices used in the treatment of bleeding vessels, tested in an experimental setting using the compact Erlangen Active Simulator for Interventional Endoscopy (compactEASIE) training model.

BACKGROUND AND STUDY AIMS: Hemoclip therapy is a well-established procedure in the treatment of gastrointestinal bleeding. Although new products are provided periodically by the industry, comparative investigations are lacking. We compared two different hemoclip devices in an experimental setting, assessing them using objective hemostatic parameters. MATERIALS AND METHODS: We compared two disposable clip devices (Olympus HX-200L-135 (n = 40) vs. Wilson-Cook Tri-Clip (n = 40)) in an experimental setting using the compact Erlangen Active Simulator for Interventional Endoscopy (compactEASIE) training model equipped with an upper gastrointestinal-organ package for bleeding simulation. This was a randomized, prospective, controlled trial. Four investigators with different levels of endoscopic experience applied ten hemoclip devices of each type to the spurting vessels, the clips allocated using a randomized list for each investigator. The efficacy of hemostasis was determined by continuous measurement of the pressure within the afferent vessel before and after clip application and calculation of the relative reduction of vessel diameter by the clip device. The system pressure was recorded over the period from 1 minute before to 1 minute after clip application. A secondary end point was a subjective assessment of the whole clip application procedure by the endoscopist and the assisting nurse, using a visual analog scale (0 - 100, with 100 representing the best experience). RESULTS: A total of 39/40 clips of each type were applied successfully. Both clip devices led to a significant increase in system pressure, representing significant relative reduction of vessel diameter (Olympus 5.4 +/- 7.5 %, p < 0.001; Cook 4.9 +/- 8.0 %, p < 0.001). Overall, there was no significant difference between the two devices ( P = 0.756). However, the investigator with the least experience in endoscopy (< 100 procedures) produced significantly inferior results compared with the other three investigators, who had performed between 2000 and 6000 procedures each ( P < 0.05). We found no evidence of a learning curve from the intra-observer results. The devices received good, but not significantly different, overall ratings by the endoscopists (Olympus 69 +/- 24 vs. Wilson-Cook 65 +/- 16) and by the assisting nurses (Olympus 77 +/- 9 vs. Wilson-Cook 70 +/- 22). CONCLUSIONS: Using an established cadaveric training model, no significant difference was found between the two types of hemoclip devices with respect to their "hemostatic efficacy". However, the experience of the endoscopist appears to play a major role in successful clip application. The use of a feedback mechanism in emergency endoscopy training, using continuous intravessel pressure monitoring, may substantially enhance the efficacy of training, resulting in a similar improvement in clinical results.

Cadaver↗

PubMed2006

Hemodynamic efficacy of the new resolution clip device in comparison with high-volume injection therapy in spurting bleeding: a prospective experimental trial using the compactEASIE simulator.

BACKGROUND AND STUDY AIMS: Peptic ulcers are the most frequent cause of gastrointestinal bleeding. The use of hemoclips has become established as an effective form of treatment in addition to injection therapy. However, hemoclips have not previously been compared with injection therapy in an experimental setting using objective parameters. MATERIALS AND METHODS: In a prospective, randomized, and controlled trial, the disposable Resolution hemoclip device (Boston Scientific, n = 40) was compared with conventional injection therapy (n = 40) in an experimental setting, using the compactEASIE simulator equipped with an upper gastrointestinal organ package to simulate bleeding. Four investigators with different levels of endoscopic experience participated in the study. On a randomized basis, each investigator treated 20 bleeding sites either by applying one clip (n = 10) or by carrying out high-volume four-quadrant injection (4 x 10 ml saline) of a spurting vessel. The efficacy of the hemostasis was assessed by continuous measurement of pressure within the afferent vessel before and after clip application or injection therapy and calculating the relative reduction in the vessel's diameter with each treatment method. The system pressure was recorded 1 min before and 1 min after treatment. The ease of application of each method was rated by the endoscopist and by the assisting nurse using a visual analogue scale (0 - 100, with 100 being best). RESULTS: All of the 40 hemoclipping and injection treatments were carried out successfully. Both methods led to a significant increase in peak pressure (Resolution clip 71.8 +/- 66.8 mm Hg, P < 0.001; injection 71.9 +/- 53.8 mm Hg, P < 0.001), representing a significant relative reduction in the vessel diameter. There were no significant differences in peak pressure between the two treatments ( P = 0.995). The mean increase in pressure during the first minute after the intervention (clip 49.3 +/- 67.0 mm Hg vs. injection 19.9 +/- 41.6 mm Hg) was significantly greater with the hemoclipping procedure ( P = 0.021). More experienced investigators achieved a greater increase in system pressure, but the difference was not significant. The assessments of the ease of application by the assistants (84 +/- 13) and endoscopists (86 +/- 16) did not show any significant differences ( P = 0.402) for the clipping device. CONCLUSIONS: No significant differences between the two treatment methods were detected with regard to the immediate efficacy of hemostasis. However, long-term hemostasis was better with hemoclipping. The endoscopist's level of experience also appears to play a role, particularly when hemoclips are used.

Animals↗

PubMed2005

Objective benefit of a 1-day training course in endoscopic hemostasis using the "compactEASIE" endoscopy simulator.

BACKGROUND AND STUDY AIMS: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 as a training model for interventional endoscopy. Objective evidence of the benefits of training with this model has not previously been published. As part of two long-term projects, the benefits of a 1-day training course with the "compactEASIE" simulator were evaluated. MATERIALS AND METHODS: Fourteen American and 18 French gastroenterology fellows were enrolled. These fellows were participants in the intensive groups performing training in endoscopic hemostasis, with a total number of 28 fellows in New York and 36 in France. Gastrointestinal endoscopy faculty members in New York and France evaluated and timed the fellows in four disciplines to establish baseline skills (manual skills; injection and coagulation; Hemoclip application; and variceal ligation) with the compactEASIE simulator. The trainees were reevaluated after an intensive 1-day course (with two or three fellows and one instructor per station), also including preparation and assistance for each procedure. The assessment (overall and parts) was done by expert tutors using an ordinal scale ranging from 1 to 10 (1 = poorest, 10 = best), recording also mistakes and performance time. The compactEASIE simulator, equipped with an upper gastrointestinal organ package and an artificial blood perfusion system, was used as the training tool. RESULTS: A highly significant improvement ( P < or = 0.001) was observed in the performance of all endoscopic techniques. A significant reduction in performance time was also observed with three of the four endoscopic techniques. Successful hemostasis was significantly improved in two out of three techniques. CONCLUSIONS: A 1-day training course on endoscopic hemostasis using the compactEASIE simulator is capable of improving the performance of hemostasis procedures. Long-term effects of repeated training sessions are currently subject of collaborative studies in New York and France.

Clinical Competence↗

PubMed2005

Significance of salicylate intolerance in diseases of the lower gastrointestinal tract.

Salicylate intolerance is defined as a nonspecific antigen-induced pseudo-allergic hypersensitivity reaction which can occur upon contact of an organism with salicylic acid, its derivatives or other related organic or inorganic acids of similar chemical structure. Since the effects of nonsteroidal anti-inflammatory drugs (NSAID) intolerance are by no means always severe or life-endangering but may just as well present as oligosymptomatic or local disorders (e.g. abdominal pain, diarrhea, we decided to evaluate the characteristics of patients with salicylate intolerance on the basis of gastroenterological case material of Medical Department I of Erlangen University. On the basis of the findings from the Erlangen interdisciplinary data register of chronic inflammatory gastrointestinal disease, the signs and symptoms of NSAID intolerance were found to constitute a diagnosis of great practical import to clinical medicine (allergology, dermatology, immunology, other disorders etc.) including gastroenterology. For approx. 2-7% of all patients with inflammatory bowel syndrome and food allergies this poses a new diagnostic and therapeutic challenge which may concern physicians from any of the disciplines involved. When presented with patients with chronic active disease who are suffering from these symptoms one should, therefore, in future give greater thought to the possibility of salicylate intolerance, all the more as there are meaningful dietetic, diagnostic and therapeutic options available for these persons.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2004

The compact Erlangen Active Simulator for Interventional Endoscopy: a prospective comparison in structured team-training courses on "endoscopic hemostasis" for doctors and nurses to the "Endo-Trainer" model.

BACKGROUND: In 1997 Hochberger and Neumann presented the "Erlangen Biosimulation Model" (commercialized as the "Erlangen Endo-Trainer") at various national and international meetings. The new compactEASIE is a simplified version of the original "Biosimulation Model" (Endo-Trainer) and is specially designed for easy handling. CompactEASIE is reduced in its features, focusing exclusively on flexible endoscopy training. The acceptance of training in endoscopic hemostasis is accepted by workshop participants, as evaluated by a questionnaire on both models. METHODS: Eleven structured courses on endoscopic hemostasis for doctors and nurses organized by the same endoscopists from 3/1998 to 5/1999 were evaluated using one of both models. The questionnaires were filled in by 207/291 trainees (71%). The Endo-Trainer was used in 4 (n = 103) and the compactEASIE in 7 courses (n = 104). Both simulators were equipped with identical types of specially prepared pig-organ packages consisting of esophagus, stomach and duodenum, including artificial sewn-in vessels, polyps and varices. Blood perfusion was done with a roller pump connected to the sewn-in vessels and blood surrogate. All workshops were identical concerning the course structure: a 30-min theoretical introduction on ulcer bleeding was followed by 2 h of practical training in injection techniques and hemoclip application. The second part of variceal therapy consisted of a 30-min theoretical introduction prior to 2 h of practical training on sclerotherapy, band ligation and cyanoacrylate application. Finally, a questionnaire on the trainees' pre-experience and their rating of the different workshop sections was handed out to each participant. RESULTS: Previous endoscopic experience was comparable in both groups. The training in both simulators was highly accepted by the trainees (compactEASIE 95% excellent and good versus EASIE (Endo-Trainer) 97%) and did not show any significant difference (P = 0.493). Even in the assessment of the single techniques, no statistical difference was observed. Furthermore, the assessments of the closeness to reality and the endoscopic environment in both simulators were identical. CONCLUSIONS: Both simulators (Endo-Trainer, compactEASIE) are excellent educational tools for interventional endoscopy with a high level of acceptance. The easy-to-handle, "lightweight" compactEASIE is a significant, progress tool for the future.

Clinical Competence↗