PBP vs Traditional Training: the T-REC Trial

Educational Problems Clinical Trial

— T-REC  

Official title:

Proficiency Based Progression Training Versus Traditional Training During a Robotic Emergency Conversion Due to a Vessel Injury in a Simulated Setting: a Prospective, Randomized, Multicenter Clinical Trial: The T-REC Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06147128
• Other study ID #: T-REC
• Status: Enrolling by invitation
• Start date: August 10, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: Orsi Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: January 31, 2024
• Est. primary completion date: December 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Educational Problems

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Belgium	Orsi Academy	Melle	Oost - Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Orsi Academy

Country where clinical trial is conducted

Belgium, 

References & Publications (16)

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. — View Citation

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 B — View Citation

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/b — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 an — View Citation

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. — View Citation

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. — View Citation

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: 10.109 — View Citation

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 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between PBP training versus traditional training for an emergency scenario where an open conversion is necessary due to a (simulated) vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.	Proficiency level will be determined by objectively assessed, validated, binary performance operative metrics where the proficiency benchmark is defined on the mean of the objectively assessed performance of experienced practitioners.; The aim of this study is to report the main performance outcomes of the T-REC trial. The investigators will compare differences between four groups in performance level as assessed by binary performance metrics of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.; The four groups deffers for the training methodology used (PBP vs traditional training). The dependant variables will be the i) time required to complete the procedure, ii) the number of procedure steps completed, iii) the number of errors made, iv) the number of critical errors made and whether the procedure was completed or not.	1 year
Secondary	Trainee's satisfaction as assessed by questionnaire. Does it influence outcome of surgical training? Comparison between PBP training versus traditional training group.	Satisfaction of a surgical trainee is often thought to be key for training quality and a predictor of good outcome of surgical training. At the end of the T-REC trial, all participants were asked to complete an online questionnaire where their satisfaction with the adopted training method was asked for using a Likert scale.; Hypothesis is that trainee's satisfaction does NOT correlate with training outcome and that satisfaction is NOT a good determinator of training quality.	2 years
Secondary	Correlation between live and video-based scoring of surgical performance	Surgical performance is often assessed live during surgery. However, one might miss specific details of performance. A possible answer to this query lies in video-based scoring of a surgical task. However, does video-based scoring reflects the same surgical quality? Moreover, one could question the ethical aspect of non-live scoring of surgical performance.; In the T-REC trial, all surgical tasks were scored live and video-based afterwards. The correlation in metrics-based performance scores between live and video-based assessment will be investigated.; Hypothesis is that there will be no differences. The investigators will try to answer the question which scoring method will give the trainee the highest chance of reaching proficiency?	2 years
Secondary	Reporting the outcome of the e-learning scores from an online proficiency questionnaire on an online learning platform.	During the T-REC trial, all participants will be required to complete an online assessment. This will done on an online learning platform. A proficiency benchmark will be defined based on the mean score of experts on the same assessment. The PBP group will be required to pass this assessment in order to move forward to the clinical training in the lab. The Control group will be required to complete the exact same online assessment before and after their training and after performing the final task. The investigators aim to do a comparison between proficiency based progression training versus traditional training for a emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system task in the regard of the e-learning scores.	2 years

External Links

•   Gallagher Anthony, O'Sullivan Gerarld. Fundamentals of Surgical Simulation [Internet]. London: Springer London; 2012