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

NCT ID: NCT04898803

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2022-12-14

Brief Summary

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.

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..

Conditions

Physicians Gastroscopy Training

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

conventional gastroscopy training course

physicians receive the DGVS-recommended training, consisting of a 2-day course with 1 hour of simulator training

conventional DGVS training

Intervention Type: OTHER

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.

extended simulator training

Intervention Type: OTHER

see above

Interventions

conventional DGVS training

see above

Intervention Type: OTHER

extended simulator training

see above

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Olympus Deutschland GmbH

UNKNOWN

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Thomas Rösch

Clinical Director, Department of Interdisciplinary Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Rösch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Hospital Eppendorf

Hamburg, , Germany

Albertinen Krankenhaus

Hamburg, , Germany

Countries

Germany

References

Amiot A, Conroy G, Le Baleur Y, Winkler J, Palazzo M, Treton X. Endoscopic training: A nationwide survey of French fellows in gastroenterology. Clin Res Hepatol Gastroenterol. 2018 Apr;42(2):160-167. doi: 10.1016/j.clinre.2017.08.005. Epub 2017 Sep 18.

Reference Type: BACKGROUND

PMID: 28927657 (View on PubMed)

Jirapinyo P, Thompson CC. Current status of endoscopic simulation in gastroenterology fellowship training programs. Surg Endosc. 2015 Jul;29(7):1913-9. doi: 10.1007/s00464-014-3884-0. Epub 2014 Oct 11.

Reference Type: BACKGROUND

PMID: 25303910 (View on PubMed)

Ende A, Zopf Y, Konturek P, Naegel A, Hahn EG, Matthes K, Maiss J. Strategies for training in diagnostic upper endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2012 Feb;75(2):254-60. doi: 10.1016/j.gie.2011.07.063. Epub 2011 Dec 7.

Reference Type: BACKGROUND

PMID: 22153875 (View on PubMed)

Haycock A, Koch AD, Familiari P, van Delft F, Dekker E, Petruzziello L, Haringsma J, Thomas-Gibson S. Training and transfer of colonoscopy skills: a multinational, randomized, blinded, controlled trial of simulator versus bedside training. Gastrointest Endosc. 2010 Feb;71(2):298-307. doi: 10.1016/j.gie.2009.07.017. Epub 2009 Nov 3.

Reference Type: BACKGROUND

PMID: 19889408 (View on PubMed)

Sedlack RE, Kolars JC, Alexander JA. Computer simulation training enhances patient comfort during endoscopy. Clin Gastroenterol Hepatol. 2004 Apr;2(4):348-52. doi: 10.1016/s1542-3565(04)00067-9.

Reference Type: BACKGROUND

PMID: 15067632 (View on PubMed)

Shirai Y, Yoshida T, Shiraishi R, Okamoto T, Nakamura H, Harada T, Nishikawa J, Sakaida I. Prospective randomized study on the use of a computer-based endoscopic simulator for training in esophagogastroduodenoscopy. J Gastroenterol Hepatol. 2008 Jul;23(7 Pt 1):1046-50. doi: 10.1111/j.1440-1746.2008.05457.x. Epub 2008 Jun 28.

Reference Type: BACKGROUND

PMID: 18554236 (View on PubMed)

Ahlberg G, Hultcrantz R, Jaramillo E, Lindblom A, Arvidsson D. Virtual reality colonoscopy simulation: a compulsory practice for the future colonoscopist? Endoscopy. 2005 Dec;37(12):1198-204. doi: 10.1055/s-2005-921049.

Reference Type: BACKGROUND

PMID: 16329017 (View on PubMed)

Cohen J, Cohen SA, Vora KC, Xue X, Burdick JS, Bank S, Bini EJ, Bodenheimer H, Cerulli M, Gerdes H, Greenwald D, Gress F, Grosman I, Hawes R, Mullin G, Schnoll-Sussman F, Starpoli A, Stevens P, Tenner S, Villanueva G. Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy. Gastrointest Endosc. 2006 Sep;64(3):361-8. doi: 10.1016/j.gie.2005.11.062.

Reference Type: BACKGROUND

PMID: 16923483 (View on PubMed)

Di Giulio E, Fregonese D, Casetti T, Cestari R, Chilovi F, D'Ambra G, Di Matteo G, Ficano L, Delle Fave G. Training with a computer-based simulator achieves basic manual skills required for upper endoscopy: a randomized controlled trial. Gastrointest Endosc. 2004 Aug;60(2):196-200. doi: 10.1016/s0016-5107(04)01566-4.

Reference Type: BACKGROUND

PMID: 15278044 (View on PubMed)

Ferlitsch A, Schoefl R, Puespoek A, Miehsler W, Schoeniger-Hekele M, Hofer H, Gangl A, Homoncik M. Effect of virtual endoscopy simulator training on performance of upper gastrointestinal endoscopy in patients: a randomized controlled trial. Endoscopy. 2010 Dec;42(12):1049-56. doi: 10.1055/s-0030-1255818. Epub 2010 Oct 22.

Reference Type: BACKGROUND

PMID: 20972956 (View on PubMed)

Maiss J, Millermann L, Heinemann K, Naegel A, Peters A, Matthes K, Hahn EG, Hochberger J. The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial. Dig Liver Dis. 2007 Jan;39(1):70-8; discussion 79-80. doi: 10.1016/j.dld.2006.07.007. Epub 2006 Aug 30.

Reference Type: BACKGROUND

PMID: 16942923 (View on PubMed)

McIntosh KS, Gregor JC, Khanna NV. Computer-based virtual reality colonoscopy simulation improves patient-based colonoscopy performance. Can J Gastroenterol Hepatol. 2014 Apr;28(4):203-6. doi: 10.1155/2014/804367.

Reference Type: BACKGROUND

PMID: 24729994 (View on PubMed)

Park J, MacRae H, Musselman LJ, Rossos P, Hamstra SJ, Wolman S, Reznick RK. Randomized controlled trial of virtual reality simulator training: transfer to live patients. Am J Surg. 2007 Aug;194(2):205-11. doi: 10.1016/j.amjsurg.2006.11.032.

Reference Type: BACKGROUND

PMID: 17618805 (View on PubMed)

Sedlack RE, Kolars JC. Computer simulator training enhances the competency of gastroenterology fellows at colonoscopy: results of a pilot study. Am J Gastroenterol. 2004 Jan;99(1):33-7. doi: 10.1111/j.1572-0241.2004.04007.x.

Reference Type: BACKGROUND

PMID: 14687137 (View on PubMed)

Tuggy ML. Virtual reality flexible sigmoidoscopy simulator training: impact on resident performance. J Am Board Fam Pract. 1998 Nov-Dec;11(6):426-33. doi: 10.3122/jabfm.11.6.426.

Reference Type: BACKGROUND

PMID: 9875997 (View on PubMed)

Yi SY, Ryu KH, Na YJ, Woo HS, Ahn W, Kim WS, Lee DY. Improvement of colonoscopy skills through simulation-based training. Stud Health Technol Inform. 2008;132:565-7.

Reference Type: BACKGROUND

PMID: 18391369 (View on PubMed)

Grover SC, Garg A, Scaffidi MA, Yu JJ, Plener IS, Yong E, Cino M, Grantcharov TP, Walsh CM. Impact of a simulation training curriculum on technical and nontechnical skills in colonoscopy: a randomized trial. Gastrointest Endosc. 2015 Dec;82(6):1072-9. doi: 10.1016/j.gie.2015.04.008. Epub 2015 May 23.

Reference Type: BACKGROUND

PMID: 26007221 (View on PubMed)

Grover SC, Scaffidi MA, Khan R, Garg A, Al-Mazroui A, Alomani T, Yu JJ, Plener IS, Al-Awamy M, Yong EL, Cino M, Ravindran NC, Zasowski M, Grantcharov TP, Walsh CM. Progressive learning in endoscopy simulation training improves clinical performance: a blinded randomized trial. Gastrointest Endosc. 2017 Nov;86(5):881-889. doi: 10.1016/j.gie.2017.03.1529. Epub 2017 Mar 31.

Reference Type: BACKGROUND

PMID: 28366440 (View on PubMed)

A Simulation-Based Training Curriculum of Progressive Fidelity and Complexity Improves Technical and Non-Technical Skills in Colonoscopy: a Blinded, Randomized Trial

Reference Type: BACKGROUND

Harewood GC, Murray F, Winder S, Patchett S. Evaluation of formal feedback on endoscopic competence among trainees: the EFFECT trial. Ir J Med Sci. 2008 Sep;177(3):253-6. doi: 10.1007/s11845-008-0161-z. Epub 2008 Jun 27.

Reference Type: BACKGROUND

PMID: 18584274 (View on PubMed)

IMPACT OF A GAME-BASED LEARNING INTERVENTION IN SIMULATION-BASED ENDOSCOPY TRAINING ON COLONOSCOPY PERFORMANCE IN NOVICE ENDOSCOPISTS - A RANDOMIZED CONTROLLED TRIAL

Reference Type: BACKGROUND

Hashimoto DA, Petrusa E, Phitayakorn R, Valle C, Casey B, Gee D. A proficiency-based virtual reality endoscopy curriculum improves performance on the fundamentals of endoscopic surgery examination. Surg Endosc. 2018 Mar;32(3):1397-1404. doi: 10.1007/s00464-017-5821-5. Epub 2017 Aug 15.

Reference Type: BACKGROUND

PMID: 28812161 (View on PubMed)

Ritter EM, Taylor ZA, Wolf KR, Franklin BR, Placek SB, Korndorffer JR Jr, Gardner AK. Simulation-based mastery learning for endoscopy using the endoscopy training system: a strategy to improve endoscopic skills and prepare for the fundamentals of endoscopic surgery (FES) manual skills exam. Surg Endosc. 2018 Jan;32(1):413-420. doi: 10.1007/s00464-017-5697-4. Epub 2017 Jul 11.

Reference Type: BACKGROUND

PMID: 28698900 (View on PubMed)

Hatala R, Cook DA, Zendejas B, Hamstra SJ, Brydges R. Feedback for simulation-based procedural skills training: a meta-analysis and critical narrative synthesis. Adv Health Sci Educ Theory Pract. 2014 May;19(2):251-72. doi: 10.1007/s10459-013-9462-8. Epub 2013 May 28.

Reference Type: BACKGROUND

PMID: 23712700 (View on PubMed)

Kruglikova I, Grantcharov TP, Drewes AM, Funch-Jensen P. The impact of constructive feedback on training in gastrointestinal endoscopy using high-fidelity Virtual-Reality simulation: a randomised controlled trial. Gut. 2010 Feb;59(2):181-5. doi: 10.1136/gut.2009.191825. Epub 2009 Oct 13.

Reference Type: BACKGROUND

PMID: 19828469 (View on PubMed)

Mahmood T, Darzi A. The learning curve for a colonoscopy simulator in the absence of any feedback: no feedback, no learning. Surg Endosc. 2004 Aug;18(8):1224-30. doi: 10.1007/s00464-003-9143-4. Epub 2004 Jun 23.

Reference Type: BACKGROUND

PMID: 15457382 (View on PubMed)

Vilmann AS, Norsk D, Svendsen MBS, Reinhold R, Svendsen LB, Park YS, Konge L. Computerized feedback during colonoscopy training leads to improved performance: a randomized trial. Gastrointest Endosc. 2018 Nov;88(5):869-876. doi: 10.1016/j.gie.2018.07.008. Epub 2018 Jul 19.

Reference Type: BACKGROUND

PMID: 30031803 (View on PubMed)

Walsh CM, Ling SC, Wang CS, Carnahan H. Concurrent versus terminal feedback: it may be better to wait. Acad Med. 2009 Oct;84(10 Suppl):S54-7. doi: 10.1097/ACM.0b013e3181b38daf.

Reference Type: BACKGROUND

PMID: 19907387 (View on PubMed)

Berger-Richardson D, Kurashima Y, von Renteln D, Kaneva P, Feldman LS, Fried GM, Vassiliou MC. Description and Preliminary Evaluation of a Low-Cost Simulator for Training and Evaluation of Flexible Endoscopic Skills. Surg Innov. 2016 Apr;23(2):183-8. doi: 10.1177/1553350615604054. Epub 2015 Sep 3.

Reference Type: BACKGROUND

PMID: 26337331 (View on PubMed)

Jirapinyo P, Abidi WM, Aihara H, Zaki T, Tsay C, Imaeda AB, Thompson CC. Preclinical endoscopic training using a part-task simulator: learning curve assessment and determination of threshold score for advancement to clinical endoscopy. Surg Endosc. 2017 Oct;31(10):4010-4015. doi: 10.1007/s00464-017-5436-x. Epub 2017 Feb 22.

Reference Type: BACKGROUND

PMID: 28229238 (View on PubMed)

Thompson CC, Jirapinyo P, Kumar N, Ou A, Camacho A, Lengyel B, Ryan MB. Development and initial validation of an endoscopic part-task training box. Endoscopy. 2014 Sep;46(9):735-44. doi: 10.1055/s-0034-1365463. Epub 2014 Apr 25.

Reference Type: BACKGROUND

PMID: 24770972 (View on PubMed)

Koch AD, Ekkelenkamp VE, Haringsma J, Schoon EJ, de Man RA, Kuipers EJ. Simulated colonoscopy training leads to improved performance during patient-based assessment. Gastrointest Endosc. 2015 Mar;81(3):630-6. doi: 10.1016/j.gie.2014.09.014. Epub 2014 Dec 2.

Reference Type: BACKGROUND

PMID: 25475901 (View on PubMed)

Vassiliou MC, Kaneva PA, Poulose BK, Dunkin BJ, Marks JM, Sadik R, Sroka G, Anvari M, Thaler K, Adrales GL, Hazey JW, Lightdale JR, Velanovich V, Swanstrom LL, Mellinger JD, Fried GM. Global Assessment of Gastrointestinal Endoscopic Skills (GAGES): a valid measurement tool for technical skills in flexible endoscopy. Surg Endosc. 2010 Aug;24(8):1834-41. doi: 10.1007/s00464-010-0882-8. Epub 2010 Jan 29.

Reference Type: BACKGROUND

PMID: 20112113 (View on PubMed)

Siau K, Crossley J, Dunckley P, Johnson G, Feeney M, Hawkes ND, Beales ILP; Joint Advisory Group on Gastrointestinal Endoscopy (JAG). Correction to: Direct observation of procedural skills (DOPS) assessment in diagnostic gastroscopy: nationwide evidence of validity and competency development during training. Surg Endosc. 2020 Jan;34(1):115. doi: 10.1007/s00464-019-06776-0.

Reference Type: BACKGROUND

PMID: 30937617 (View on PubMed)

ASGE Training Committee; Sedlack RE, Coyle WJ, Obstein KL, Al-Haddad MA, Bakis G, Christie JA, Davila RE, DeGregorio B, DiMaio CJ, Enestvedt BK, Jorgensen J, Mullady DK, Rajan L. ASGE's assessment of competency in endoscopy evaluation tools for colonoscopy and EGD. Gastrointest Endosc. 2014 Jan;79(1):1-7. doi: 10.1016/j.gie.2013.10.003. Epub 2013 Nov 14. No abstract available.

Reference Type: BACKGROUND

PMID: 24239255 (View on PubMed)

van Dongen KW, Verleisdonk EJ, Schijven MP, Broeders IA. Will the Playstation generation become better endoscopic surgeons? Surg Endosc. 2011 Jul;25(7):2275-80. doi: 10.1007/s00464-010-1548-2. Epub 2011 Mar 17.

Reference Type: BACKGROUND

PMID: 21416186 (View on PubMed)

Scaffidi MA, Grover SC, Carnahan H, Yu JJ, Yong E, Nguyen GC, Ling SC, Khanna N, Walsh CM. A prospective comparison of live and video-based assessments of colonoscopy performance. Gastrointest Endosc. 2018 Mar;87(3):766-775. doi: 10.1016/j.gie.2017.08.020. Epub 2017 Aug 30.

Reference Type: BACKGROUND

PMID: 28859953 (View on PubMed)

Sewell JL, Boscardin CK, Young JQ, Ten Cate O, O'Sullivan PS. Measuring cognitive load during procedural skills training with colonoscopy as an exemplar. Med Educ. 2016 Jun;50(6):682-92. doi: 10.1111/medu.12965.

Reference Type: BACKGROUND

PMID: 27170086 (View on PubMed)

Sewell JL, Boscardin CK, Young JQ, Ten Cate O, O'Sullivan PS. Learner, Patient, and Supervisor Features Are Associated With Different Types of Cognitive Load During Procedural Skills Training: Implications for Teaching and Instructional Design. Acad Med. 2017 Nov;92(11):1622-1631. doi: 10.1097/ACM.0000000000001690.

Reference Type: BACKGROUND

PMID: 28445213 (View on PubMed)

Thomas-Gibson S, Saunders BP. Development and validation of a multiple-choice question paper in basic colonoscopy. Endoscopy. 2005 Sep;37(9):821-6. doi: 10.1055/s-2005-870202.

Reference Type: BACKGROUND

PMID: 16116532 (View on PubMed)

Bini EJ, Firoozi B, Choung RJ, Ali EM, Osman M, Weinshel EH. Systematic evaluation of complications related to endoscopy in a training setting: A prospective 30-day outcomes study. Gastrointest Endosc. 2003 Jan;57(1):8-16. doi: 10.1067/mge.2003.15.

Reference Type: BACKGROUND

PMID: 12518123 (View on PubMed)

Fudman DI, Falchuk KR, Feuerstein JD. Complication rates of trainee- versus attending-performed upper gastrointestinal endoscopy. Ann Gastroenterol. 2019 May-Jun;32(3):273-277. doi: 10.20524/aog.2019.0372. Epub 2019 Mar 28.

Reference Type: BACKGROUND

PMID: 31040624 (View on PubMed)

Related Links

http://www.dgvs.de/fortbildung-aktuell/zertifizierung-endoskopischer-trainingskurse/

certification of endoscopic training by DGVS

Other Identifiers

PV7217

Identifier Type: -

Identifier Source: org_study_id