Study Results
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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ENROLLING_BY_INVITATION
48 participants
OBSERVATIONAL
2023-08-10
2024-01-31
Brief Summary
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Detailed Description
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Group 1 will receive standard training for both TS and NTS. Group 2 will receive PBP training for TS and standard training for NTS. Group 3 will receive standard training for TS and PBP training for NTS. Group 4 will receive PBP training for both TS and NTS.
All four group will receive the same e-learning on TS and NTS (on an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery on a dry lab model). The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., for the e-learning, TS and NTS). The Traditional trained group will train in the same laboratory for a case-matched period of time as the PBP group, with the same level of supervising faculty proctors and using the same training resources but with no proficiency benchmarks.
Investigators will be trained in pairs to assess performance from a pre-defined set of explicitly defined binary metric events reliably (inter-rater reliability \> 0.8). They will also be blinded as to the identity of the trainee performing the procedure, how they were trained (i.e., group) and procedure order.
H1 It is hypothesized that implementation of PBP training in teaching TS and NTS for surgeons in the context of an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery, leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to traditional training.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Active Comparator: Traditional Trained
Trainees in the Traditional trained group will have an e-learning didactic component (specifically on the steps of the procedure, clinical aspects of the procedure, published evidence etc) which they must complete before training by a procedure expert. On completion of the e-learning module the trainees will complete a summative assessment of their knowledge. The trainees will then be shown how and then trained to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery task. The scenario will be demonstrated initially by an expert and who will then proctor the trainees in the same technique.
Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Experimental: PBP for Technical emergency undocking skills
Participants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge on TS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical skills.
Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Experimental: PBP for Non-Technical emergency undocking skills
Participants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge on NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of non-technical skills.
Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Experimental: PBP for Technical and Non-Technical emergency undocking skills
Participants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge on both TS and NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical and non-technical skills.
Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Interventions
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Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to perform a laparotomy
Exclusion Criteria
18 Years
99 Years
ALL
Yes
Sponsors
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Orsi Academy
OTHER
Responsible Party
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Principal Investigators
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Claudia CollĂ Ruvolo, MD
Role: PRINCIPAL_INVESTIGATOR
Orsi Academy
Locations
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Orsi Academy
Melle, Oost - Vlaanderen, Belgium
Countries
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References
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Pellegrini CA. Surgical education in the United States: navigating the white waters. Ann Surg. 2006 Sep;244(3):335-42. doi: 10.1097/01.sla.0000234800.08200.6c. No abstract available.
Cuschieri A. Whither minimal access surgery: tribulations and expectations. Am J Surg. 1995 Jan;169(1):9-19. doi: 10.1016/s0002-9610(99)80104-4. No abstract available.
Gallagher AG. Metric-based simulation training to proficiency in medical education:- what it is and how to do it. Ulster Med J. 2012 Sep;81(3):107-13.
Gallagher AG, Ritter EM, Champion H, Higgins G, Fried MP, Moses G, Smith CD, Satava RM. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Ann Surg. 2005 Feb;241(2):364-72. doi: 10.1097/01.sla.0000151982.85062.80.
Breen D, O'Brien S, McCarthy N, Gallagher A, Walshe N. Effect of a proficiency-based progression simulation programme on clinical communication for the deteriorating patient: a randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e025992. doi: 10.1136/bmjopen-2018-025992.
Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099.
Cates CU, Lonn L, Gallagher AG. Prospective, randomised and blinded comparison of proficiency-based progression full-physics virtual reality simulator training versus invasive vascular experience for learning carotid artery angiography by very experienced operators. BMJ Simul Technol Enhanc Learn. 2016 Feb 8;2(1):1-5. doi: 10.1136/bmjstel-2015-000090. eCollection 2016.
Angelo RL, Ryu RK, Pedowitz RA, Beach W, Burns J, Dodds J, Field L, Getelman M, Hobgood R, McIntyre L, Gallagher AG. A Proficiency-Based Progression Training Curriculum Coupled With a Model Simulator Results in the Acquisition of a Superior Arthroscopic Bankart Skill Set. Arthroscopy. 2015 Oct;31(10):1854-71. doi: 10.1016/j.arthro.2015.07.001. Epub 2015 Sep 2.
Van Sickle KR, Ritter EM, Baghai M, Goldenberg AE, Huang IP, Gallagher AG, Smith CD. Prospective, randomized, double-blind trial of curriculum-based training for intracorporeal suturing and knot tying. J Am Coll Surg. 2008 Oct;207(4):560-8. doi: 10.1016/j.jamcollsurg.2008.05.007. Epub 2008 Jul 14.
Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA 3rd, Ramel S, Smith CD, Arvidsson D. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg. 2007 Jun;193(6):797-804. doi: 10.1016/j.amjsurg.2006.06.050.
Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002 Oct;236(4):458-63; discussion 463-4. doi: 10.1097/00000658-200210000-00008.
de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008 Jun;17(3):216-23. doi: 10.1136/qshc.2007.023622.
Gawande AA, Zinner MJ, Studdert DM, Brennan TA. Analysis of errors reported by surgeons at three teaching hospitals. Surgery. 2003 Jun;133(6):614-21. doi: 10.1067/msy.2003.169.
Greenberg CC, Regenbogen SE, Studdert DM, Lipsitz SR, Rogers SO, Zinner MJ, Gawande AA. Patterns of communication breakdowns resulting in injury to surgical patients. J Am Coll Surg. 2007 Apr;204(4):533-40. doi: 10.1016/j.jamcollsurg.2007.01.010.
Collins JW, Dell'Oglio P, Hung AJ, Brook NR. The Importance of Technical and Non-technical Skills in Robotic Surgery Training. Eur Urol Focus. 2018 Sep;4(5):674-676. doi: 10.1016/j.euf.2018.08.018. Epub 2018 Sep 11.
Mazzone E, Puliatti S, Amato M, Bunting B, Rocco B, Montorsi F, Mottrie A, Gallagher AG. A Systematic Review and Meta-analysis on the Impact of Proficiency-based Progression Simulation Training on Performance Outcomes. Ann Surg. 2021 Aug 1;274(2):281-289. doi: 10.1097/SLA.0000000000004650.
Related Links
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Gallagher Anthony, O'Sullivan Gerarld. Fundamentals of Surgical Simulation \[Internet\]. London: Springer London; 2012
Other Identifiers
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T-REC
Identifier Type: -
Identifier Source: org_study_id