PBP Versus Halsted's Model: the PROVESA Trial

Educational Problems Clinical Trial

— PROVESA  

Official title:

Proficiency Based Progression Training Versus the Halsted's Model for a Robotic Vesico-urethral Anastomosis on an Avian Tissue Model: a Prospective, Randomized, Multicenter and Blinded Clinical Trial: the PROVESA Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786834
• Other study ID #: PROVESA
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: March 2021
• Source: Orsi Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial aims to compare the effectiveness of Halsted's apprenticeship approach to training with the PBP approach for teaching the robotic suturing of a VUA on a chicken model.

Description:

In a prospective, randomized and blinded study robotic naïve (urology (n = 12), surgery (n = 12) and gynecology (n = 12)) residents (n = 36) from the KU Leuven and University of Gent residency training programs will be randomized (in equal discipline numbers) to Traditional Halstedian apprenticeship type training or proficiency based progression (PBP) training to learn to perform a vesico-urethral anastomosis (VUA) on a chicken model. Both groups will receive the same e-learning (on how to perform the VUA on the chicken model) and skills laboratory robotic training curriculum. The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., from e-learning to the skills lab). The PBP group will also have a defined benchmark to demonstrate before training is deemed completed. The Traditional trained group will train in the same skills 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 or metric-based feedback. Both groups will be required to perform a VUA on the chicken model before skills training proper and at the end of training. Investigators will be trained in pairs to assess VUA 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 the robotic suturing of VUA leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to Halsted's method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• recently accepted, first or second year residents gynecology and obstetrics (n=12), urology (n=12) and general surgery (n=12). Novice in robotic surgery.

Exclusion Criteria:

• Any robotic experience

Related Conditions & MeSH terms

• Educational Problems

Intervention

Procedure:
• Vesico urethral anastomosis on chicken model
Performance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system

Locations

Country	Name	City	State
Belgium	Orsi Academy	Melle	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Stefano Puliatti

Country where clinical trial is conducted

Belgium, 

References & Publications (17)

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

Cacciamani G, De Marco V, Siracusano S, De Marchi D, Bizzotto L, Cerruto MA, Motton G, Porcaro AB, Artibani W. A new training model for robot-assisted urethrovesical anastomosis and posterior muscle-fascial reconstruction: the Verona training technique. J — View Citation

Cuschieri A. Whither minimal access surgery: tribulations and expectations. Am J Surg. 1995 Jan;169(1):9-19. — View Citation

Ericsson KA. Towards a science of the acquisition of expert performance in sports: Clarifying the differences between deliberate practice and other types of practice. J Sports Sci. 2020 Jan;38(2):159-176. doi: 10.1080/02640414.2019.1688618. Epub 2019 Nov — 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. — View Citation

Gallagher AG, Ritter EM, Satava RM. Fundamental principles of validation, and reliability: rigorous science for the assessment of surgical education and training. Surg Endosc. 2003 Oct;17(10):1525-9. Epub 2003 Sep 19. — 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. Review. — View Citation

Goh AC, Goldfarb DW, Sander JC, Miles BJ, Dunkin BJ. Global evaluative assessment of robotic skills: validation of a clinical assessment tool to measure robotic surgical skills. J Urol. 2012 Jan;187(1):247-52. doi: 10.1016/j.juro.2011.09.032. Epub 2011 No — 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

Pellegrini CA. Surgical education in the United States: navigating the white waters. Ann Surg. 2006 Sep;244(3):335-42. — View Citation

Santos DRD, Calvo FC, Feijó DH, Araújo NP, Teixeira RKC, Yasojima EY. New training model using chickens intestine for pediatric intestinal anastomosis. Acta Cir Bras. 2019 Sep 16;34(7):e201900709. doi: 10.1590/s0102-865020190070000009. — 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. — View Citation

Sotelo RJ, Astigueta JC, Carmona OJ, De Andrade RJ, Moreira OE. Chicken gizzard: a new training model for laparoscopic urethrovesical anastomosis. Actas Urol Esp. 2009 Nov;33(10):1083-7. English, Spanish. — 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

Vanlander AE, Mazzone E, Collins JW, Mottrie AM, Rogiers XM, van der Poel HG, Van Herzeele I, Satava RM, Gallagher AG. Orsi Consensus Meeting on European Robotic Training (OCERT): Results from the First Multispecialty Consensus Meeting on Training in Robo — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical proficiency level determined by objectively assessed, validated, binary performance operative metrics. Comparison between PBP training versus traditional training for a robotic suturing and knot tying task.	The aim of this paper is to report the main outcomes of the PROVESA trial without emphasizing the interspecialty differences. The investigators will however emphasize its methodology, the fact that is well controlled and multicentric. Differences in proficiency level, assessed by binary performance metrics based assessment of a robotic suturing and knot tying task, will be reported.	1 year
Secondary	Cross-specialty differences in surgical proficiency levels, assessed by objectively assessed, validated, binary performance operative metrics, for a robotic suturing and knot tying task.	Surgical skill is often thought to be associated to surgical discipline. The aim of this study is to compare the objectively assessed training outcomes of different surgical disciplines (Surgery, Gynecology/obstetrics and Urology) performing the robotic suturing of a vesico-urethral anastomosis (VUA) on a chicken model. Participants were trained according to a traditional versus a proficiency based progression methodology and were assessed by the use of validated, binary performance operative metrics.	1 year
Secondary	Difference in interrater reliability for metrics-based scoring determined by objectively assessed, validated, binary performance operative metrics versus GEARS-based scoring of a robotic suturing and knot tying task.	Nowadays, different methods are used to assess surgical performance. One of the most commonly used methods is the GEARS (Global Evaluative Assessment of Robotic Skills). This is, however, a qualitative scoring method which uses a Likert scale for scoring and which might be prone to poor interrater reliability and subjectiveness.; The aim of this paper will be to report the interrater reliability of both scoring methods and the correlation between each other. Hypothesis is that interrater reliability will be superior for performance metrics. The investigators will try to answer the question which is the best tool to assess surgical performance.	2 years
Secondary	Trainee's satisfaction as assessed by questionnaire with Likert scale. Does it influence outcome of surgical training? Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.	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 PROVESA, 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 PROVESA 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. Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.	During the PROVESA trial, all participants had to do an online assessment. This was done on an online learning platform using a questionnaire. A proficiency benchmark was set based on the mean score of experts on the same questionnaire.; The PBP group needed to do this after doing an online curriculum during which the operative metrics were explained. In order to move forward to the clinical training in the lab, they had to show proficiency on the test by reaching a pre-defined benchmark.; The Control group needed to do the online assessment after their day of training and after performing the final VUA. The investigators noted a significant correlation between the score on the online assessment and the number of metrics-based performance errors. The lower the score on the online test, the more performance errors they made.; The aim of this paper will be to stipulate the importance of e-learning and online scoring and its correlation with surgical performance.	2 years