Development and Validation of a Simulator-based Test in Transurethral Resection of Bladder Tumors

• ClinicalTrials.gov Identifier: NCT03863028
• Recruitment Status: Completed
• First Posted: March 5, 2019
• Last Update Posted: March 5, 2019
• Sponsor: Rigshospitalet, Denmark
• Collaborator: Copenhagen Academy for Medical Education and Simulation
• Information provided by (Responsible Party): Sarah Hjartbro Bube, Zealand University Hospital

Study Description

Brief Summary:

Bladder cancer (BC) is the seventh most common cancer in men worldwide and fourth most common cancer among Danish men. BC is estimated to be the most cost expensive cancer pr. patient life. BC is diagnosed, staged and if possible treated with a transurethral bladder tumor resection (TUR-B).

The prognosis of BC is depending on the depth of invasion, which makes the quality of the TURB procedure of utmost importance. Retrospective studies from Sweden and Canada on resident involvement in TURB procedures indicated that the TURBs were insufficient with regard to staging and had a higher need of repeating TURB.

Surgical training for TURB in Denmark today is based on the Halstedian principle: "See one, do one, teach one", comparable to training in Sweden and Canada. Thus, there is a need to develop better and safer principles for training.

Simulators for surgical procedures have a promising role in the surgical training. The project will explore the effect of simulation training on the quality in transurethral resection of bladder tumors.

Based on our findings the principles of simulator training will be integrated in a curriculum for simulator-based TURB training for urological surgeons in Denmark.

The collaboration research group is composed of medical doctors in urological surgery at Urological Department at Zealand University Hospital, Roskilde (ROS) and experts in medical simulation at Copenhagen Academy for Medical Education and Simulation at Rigshospitalet (CAMES).

Condition or disease	Intervention/treatment
Validity-evidence for a Simulator-based Test; Virtual Simulation; Bladder Cancer; Surgical Skill Training; Medical Education; Transurethral Resection of Bladdertumors	Other: Simulation training

Detailed Description:

The incidence of bladder tumors is increasing and is more than 2,000 in Denmark. The bladder tumor is initially treated by transurethral resection (TURB) classifying the tumor by debt of invasion. The bladder wall is composed of urothelium, lamina propria and muscularis propria also known as the detrusor muscle. Bladder cancer (BC), defined as detrusor-muscle invasive tumors, are found in approximately 50% of bladder tumors. BC is the seventh most common cancer disease among men worldwide, and the fourth most common cancer in men in Denmark. Superficial bladder tumors can be treated with TURB whereas BC is treated with radical cystectomy. Thus, it is of utmost importance that TURB is done with sufficient resection of the detrusor muscle to ensure that the patient is staged correctly to optimise treatment.

TURB was first described and performed by Desormeaux in 1867 and the obstacles for the surgeon remain the same more the 150 years after. TUR-B demands haptic skills, the ability to identify the layers of the bladder wall, the ability to perceive the stiffness of the tissue through radial and tangential movements and the ability to translate two-dimensional pictures to a three-dimensional understanding and at the same time move surgical instruments around an axis.

As TUR-B is performed through the urethra with one scope only, the learner is left with observation of the master until the day occurs where the learner is trusted the scope. Thus, the gap between seeing and doing TURB remains significant.

The outcome of TURB have been shown to be dependent on surgeon-experience, with a higher risk for insufficient resections with lower surgeon experience. A recent Canadian study from a single centre showed that resident involvement in TUR-B had fewer complete resections including the detrusor muscle layer in the pathological specimen and patients had delayed time to cystectomy when compared to patients who had the TUR-B performed by attending urologists. Thus, both patient safety and quality of care are compromised when residents are involved in the treatment and staging of patients with bladder tumors.

The current education in TURB in Denmark is based on classical apprenticeship as it has been for the last 150 years, with the resident learning from a supervisor while performing TURB on patients.

Needs assessment analyses among specialists in urology and medical education in Denmark in 2017 identified TURB as a procedure in which simulation based skill acquisition are desired.

Simulation-based training is increasingly used in medical education. The opportunity to train a procedure repeatedly in a secure, stress-free environment with several different scenarios is appealing. Even though simulation-based training carries these promising opportunities, the challenge, when introducing simulation-based training, is to identify if the training transfer to actually improved performance on patients. Thus, we need to test if the simulator training leads to a level of minimum competency before progressing to performance on patients. A minimum passing standard should not be defined by amount of training, but by simulator performance outcomes.

Thus, we need to define test outcomes that identify competency before introducing a simulation-based test. Mastery learning (ML) is an educational theory in which the learner is to train until reaching a minimum acquisition level. The endpoint of the training is hereby a predefined competency level, and not an arbitrary amount of training hours. In the light of the ML framework the principle of directed self-regulated learning (DSRL) has evoked. DSRL is a learning-approach where the student regulates his/her own progress through a defined training protocol without guidance from an instructor. The theory is that this approach provides the student the opportunity to develop own strategies and to learn from mistakes, while also increasing the availability of training independent of supervision from a busy faculty.(20) DSRL can be modified to ensure that the learner do not learn unappropriated methods by either written theoretical material, video instructions, a non-expert assistant or all of them. Thus, the purpose of this trial is to develop and gather validity evidence for a simulator-based test in TURB based on the principles of ML and DSRL.

Hypothesis Overall: A simulator-based test can identify competency-levels with regard to a score based simulator metrics.

Aim of project To develop and gather validity evidence for a simulator-based test in TURB.

Research Question

• Can the test discriminate between varying competency levels?
• Can we establish a level of competency by a test in simulator-based TURB training?

Study Design

• Study Type: Observational
• Actual Enrollment: 49 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Development and Validation of a Simulator-based Test in Transurethral Resection of Bladder Tumors
• Actual Study Start Date: March 15, 2018
• Actual Primary Completion Date: September 21, 2018
• Actual Study Completion Date: September 21, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Novice; Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB	Other: Simulation training; It is not a randomized trial - all three groups are exposed to simulation training.
Intermediates; Residents who have performed 10 to 30 TURBs.	Other: Simulation training; It is not a randomized trial - all three groups are exposed to simulation training.
Experienced; Consultants with experience in the procedure defined as more than 100 TURBs.	Other: Simulation training; It is not a randomized trial - all three groups are exposed to simulation training.

Outcome Measures

Primary Outcome Measures :

1. Mean test score [ Time Frame: Through study completion, an average of 4 weeks ]
   Based on simulator metrics with significant discriminatory ability between different experience levels, a test score is constructed.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Based on previous studies on TURB simulation and surgeon depending surgical outcomes, three groups are conducted: Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB, intermediary experienced senior residents defined as surgeons who have performed between 10 and 30 TURBs and consultants with expertise in the procedure defined as more than 100 TURBs.(6,16,21,22) Residents, intermediates, and consultants at the three Urological Departments of the Zealand Region and the Capital Region will be invited to voluntary participation by written invitation. All eligible doctors will be categorised in the three groups until the sample size is reached.

Criteria

Inclusion Criteria:

• Novice: Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB.
• Intermediates: Residents who have performed 10 to 30 TURBs.
• Experienced: Consultants with experience in the procedure defined as more than 100 TURBs.
• All participants: Reasonable Danish skills and must give informed written consent to participate.

Exclusion Criteria:

• Exclusion criteria for all participants: Prior systematic experience on the Simbionix/VirtaMed UroSimTM simulator.

Contacts and Locations

Locations

Denmark

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Danmark, Denmark, 2100

Urology Department, Zealand University Hospital

Roskilde, Denmark, DK-4000

Sponsors and Collaborators

Rigshospitalet, Denmark

Copenhagen Academy for Medical Education and Simulation

More Information

Publications:

Allard CB, Meyer CP, Gandaglia G, Chang SL, Chun FK, Gelpi-Hammerschmidt F, Hanske J, Kibel AS, Preston MA, Trinh QD. The Effect of Resident Involvement on Perioperative Outcomes in Transurethral Urologic Surgeries. J Surg Educ. 2015 Sep-Oct;72(5):1018-25. doi: 10.1016/j.jsurg.2015.04.012. Epub 2015 May 21.

Bos D, Allard CB, Dason S, Ruzhynsky V, Kapoor A, Shayegan B. Impact of resident involvement in endoscopic bladder cancer surgery on pathological outcomes. Scand J Urol. 2016 Jun;50(3):234-8. doi: 10.3109/21681805.2016.1163616. Epub 2016 Apr 4.

Amin MB, Smith SC, Reuter VE, Epstein JI, Grignon DJ, Hansel DE, Lin O, McKenney JK, Montironi R, Paner GP, Al-Ahmadie HA, Algaba F, Ali S, Alvarado-Cabrero I, Bubendorf L, Cheng L, Cheville JC, Kristiansen G, Cote RJ, Delahunt B, Eble JN, Genega EM, Gulmann C, Hartmann A, Langner C, Lopez-Beltran A, Magi-Galluzzi C, Merce J, Netto GJ, Oliva E, Rao P, Ro JY, Srigley JR, Tickoo SK, Tsuzuki T, Umar SA, Van der Kwast T, Young RH, Soloway MS. Update for the practicing pathologist: The International Consultation On Urologic Disease-European association of urology consultation on bladder cancer. Mod Pathol. 2015 May;28(5):612-30. doi: 10.1038/modpathol.2014.158. Epub 2014 Nov 21. Review.

Ploeg M, Aben KK, Kiemeney LA. The present and future burden of urinary bladder cancer in the world. World J Urol. 2009 Jun;27(3):289-93. doi: 10.1007/s00345-009-0383-3. Epub 2009 Feb 15.

Jancke G, Rosell J, Jahnson S. Impact of surgical experience on recurrence and progression after transurethral resection of bladder tumour in non-muscle-invasive bladder cancer. Scand J Urol. 2014 Jun;48(3):276-83. doi: 10.3109/21681805.2013.864327. Epub 2013 Nov 29.

Mariappan P, Zachou A, Grigor KM; Edinburgh Uro-Oncology Group. Detrusor muscle in the first, apparently complete transurethral resection of bladder tumour specimen is a surrogate marker of resection quality, predicts risk of early recurrence, and is dependent on operator experience. Eur Urol. 2010 May;57(5):843-9. doi: 10.1016/j.eururo.2009.05.047. Epub 2009 Jun 6.

Nisky I, Huang F, Milstein A, Pugh CM, Mussa-Ivaldi FA, Karniel A. Perception of stiffness in laparoscopy - the fulcrum effect. Stud Health Technol Inform. 2012;173:313-9.

Gallagher AG, McClure N, McGuigan J, Ritchie K, Sheehy NP. An ergonomic analysis of the fulcrum effect in the acquisition of endoscopic skills. Endoscopy. 1998 Sep;30(7):617-20.

Mariappan P, Finney SM, Head E, Somani BK, Zachou A, Smith G, Mishriki SF, N'Dow J, Grigor KM; Edinburgh Urological Cancer Group. Good quality white-light transurethral resection of bladder tumours (GQ-WLTURBT) with experienced surgeons performing complete resections and obtaining detrusor muscle reduces early recurrence in new non-muscle-invasive bladder cancer: validation across time and place and recommendation for benchmarking. BJU Int. 2012 Jun;109(11):1666-73. doi: 10.1111/j.1464-410X.2011.10571.x. Epub 2011 Nov 1.

Herr HW, Donat SM. Quality control in transurethral resection of bladder tumours. BJU Int. 2008 Nov;102(9 Pt B):1242-6. doi: 10.1111/j.1464-410X.2008.07966.x.

Richterstetter M, Wullich B, Amann K, Haeberle L, Engehausen DG, Goebell PJ, Krause FS. The value of extended transurethral resection of bladder tumour (TURBT) in the treatment of bladder cancer. BJU Int. 2012 Jul;110(2 Pt 2):E76-9. doi: 10.1111/j.1464-410X.2011.10904.x. Epub 2012 Feb 7.

Miladi M, Peyromaure M, Zerbib M, Saïghi D, Debré B. The value of a second transurethral resection in evaluating patients with bladder tumours. Eur Urol. 2003 Mar;43(3):241-5. Review.

Naselli A, Hurle R, Paparella S, Buffi NM, Lughezzani G, Lista G, Casale P, Saita A, Lazzeri M, Guazzoni G. Role of Restaging Transurethral Resection for T1 Non-muscle invasive Bladder Cancer: A Systematic Review and Meta-analysis. Eur Urol Focus. 2018 Jul;4(4):558-567. doi: 10.1016/j.euf.2016.12.011. Epub 2017 Jan 13.

Nayahangan LJ, Bølling Hansen R, Gilboe Lindorff-Larsen K, Paltved C, Nielsen BU, Konge L. Identifying content for simulation-based curricula in urology: a national needs assessment. Scand J Urol. 2017 Dec;51(6):484-490. doi: 10.1080/21681805.2017.1352618. Epub 2017 Jul 26.

Aydin A, Ahmed K, Shafi AM, Khan MS, Dasgupta P. The role of simulation in urological training - A quantitative study of practice and opinions. Surgeon. 2016 Dec;14(6):301-307. doi: 10.1016/j.surge.2015.06.003. Epub 2015 Jul 4.

Aydin A, Raison N, Khan MS, Dasgupta P, Ahmed K. Simulation-based training and assessment in urological surgery. Nat Rev Urol. 2016 Sep;13(9):503-19. doi: 10.1038/nrurol.2016.147. Epub 2016 Aug 23. Review.

Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.

• Responsible Party: Sarah Hjartbro Bube, MD, Ph.D. student, Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT03863028
• Other Study ID Numbers: 17-000048
• First Posted: March 5, 2019
• Last Update Posted: March 5, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sarah Hjartbro Bube, Zealand University Hospital:

Validity-evidence; TURB; Mastery Learning; Bladder Cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases