PBP Versus Halsted's Model: the PROVESA Trial

NCT04786834 | Completed DMC

• 1 other identifier: PROVESA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Educational Problems

Keywords

surgery; robotics; training; vesico-urethral anastomosis; Proficiency Based Progression; Basic skills training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cross-specialty differences in surgical proficiency levels, assessed by objectively assessed, validated, binary performance operative metrics, for a robotic suturing and knot tying task.

  1 year

• 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.

  2 years

• 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.

  2 years

• Correlation between live and video-based scoring of surgical performance

  2 years

• 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.

  2 years

Study Arms (2)

Traditional training group

ACTIVE COMPARATOR

Trainees in the Traditional trained group will be trained according to the traditional approach of 'See one, do one, teach one' principle. Trainees will have an e-learning didactic component (specifically on the anatomy \& physiology 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 they will complete a summative assessment of their knowledge. They will then be shown how and then trained to suture and tie knots using the robot. The VUA will be demonstrated initially by an expert and who will then proctor the trainees in the same technique for repeated training trials., i.e., repeated practice for a period of time matched to the PBP group.

Procedure: Vesico urethral anastomosis on chicken model

Proficiency based progression (PBP) training group: a new training methodology

EXPERIMENTAL

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 before continuing to the surgical training. Their knowledge will be assessed in a formative and summative fashion. After their initial VUA assessment, procedure-specific and validated procedure metrics will be used to teach the students the steps of the procedure, as well as the correct (and incorrect) way to perform the procedure. The metrics will be used to give them performance feedback with specific advice on how they might improve their performance, i.e., deliberate practice.

Procedure: Vesico urethral anastomosis on chicken model

Interventions

Vesico urethral anastomosis on chicken model PROCEDURE

Performance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system

Proficiency based progression (PBP) training group: a new training methodology; Traditional training group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any robotic experience

Sponsors & Collaborators

• Stefano Puliatti: lead

Study Sites (1)

Orsi Academy

Melle, Oost-Vlaanderen, 9090, Belgium

Location

Related Publications (17)

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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.

  PMID: 23620606 RESULT

• 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.

  PMID: 15650649 RESULT

• 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.

  PMID: 31289064 RESULT

• 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.

  PMID: 30327396 RESULT

• 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.

  PMID: 26341047 RESULT

• 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.

  PMID: 18926460 RESULT

• 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.

  PMID: 17512301 RESULT

• 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.

  PMID: 12368674 RESULT

• 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 Robot-assisted Surgery. Eur Urol. 2020 Nov;78(5):713-716. doi: 10.1016/j.eururo.2020.02.003. Epub 2020 Feb 21.

  PMID: 32089358 RESULT

• 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 Robot Surg. 2017 Jun;11(2):123-128. doi: 10.1007/s11701-016-0626-4. Epub 2016 Jul 20.

  PMID: 27440232 RESULT

• Santos DRD, Calvo FC, Feijo DH, Araujo 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.

  PMID: 31531529 RESULT

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  PMID: 20096178 RESULT

• 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 12.

  PMID: 31718526 RESULT

• 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 Nov 17.

  PMID: 22099993 RESULT

• 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. doi: 10.1007/s00464-003-0035-4. Epub 2003 Sep 19. No abstract available.

  PMID: 14502403 RESULT

Study Officials

• Ruben De Groote, MD

  Orsi Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Medical Director

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: March 8, 2021
• Study Start: July 27, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)