PBP vs Traditional Training: the T-REC Trial

NCT ID: NCT06147128

Last Updated: 2023-11-29

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-01-31

Brief Summary

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This randomized controlled trial aims to compare the effectiveness of traditional training approach to training with the proficiency-based progression (PBP) approach for teaching the technical skills (TS) and non-technical skills (NTS) for surgeons in the context of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery.

Detailed Description

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In a prospective, randomized and blinded study surgical residents (n = 48) from Belgium university (i.e. the Katholieke Universiteit \[KU\] Leuven and University of Gent residency training programs) will be enrolled and randomized to Traditional type training proficiency-based progression (PBP) training to learn how to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model. Specifically, this study will include four independent arms, each employing different training methodologies for technical skills (TS) and non-technical skills (NTS).

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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Educational Problems

Keywords

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Training Robotic surgery Proficiency based progression Emergency undocking

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Other Intervention Names

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Robotic emergency conversion

Eligibility Criteria

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Inclusion Criteria

* recently accepted, form first to last year residents' gynecology and obstetrics, urology and general surgery.
* Ability to perform a laparotomy

Exclusion Criteria

* Any robotic experience with emergency undocking.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orsi Academy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Belgium

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.

Reference Type RESULT
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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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 23620606 (View on PubMed)

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.

Reference Type RESULT
PMID: 15650649 (View on PubMed)

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.

Reference Type RESULT
PMID: 31289064 (View on PubMed)

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.

Reference Type RESULT
PMID: 30327396 (View on PubMed)

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.

Reference Type RESULT
PMID: 35516451 (View on PubMed)

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.

Reference Type RESULT
PMID: 26341047 (View on PubMed)

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.

Reference Type RESULT
PMID: 18926460 (View on PubMed)

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.

Reference Type RESULT
PMID: 17512301 (View on PubMed)

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.

Reference Type RESULT
PMID: 12368674 (View on PubMed)

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.

Reference Type RESULT
PMID: 18519629 (View on PubMed)

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.

Reference Type RESULT
PMID: 12796727 (View on PubMed)

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.

Reference Type RESULT
PMID: 17382211 (View on PubMed)

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.

Reference Type RESULT
PMID: 30217631 (View on PubMed)

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.

Reference Type RESULT
PMID: 33630473 (View on PubMed)

Related Links

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http://link.springer.com/10.1007/978-0-85729-763-1

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