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

NCT03863028 | Completed

• 1 other identifier: 17-000048
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 2

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).

Conditions

Validity-evidence for a Simulator-based Test; Virtual Simulation; Bladder Cancer; Surgical Skill Training; Medical Education; Transurethral Resection of Bladdertumors

Keywords

Validity-evidence; TURB; Mastery Learning; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Mean test score

  Based on simulator metrics with significant discriminatory ability between different experience levels, a test score is constructed.

  Through study completion, an average of 4 weeks

Study Arms (3)

Novice

Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB

Other: Simulation training

Intermediates

Residents who have performed 10 to 30 TURBs.

Other: Simulation training

Experienced

Consultants with experience in the procedure defined as more than 100 TURBs.

Other: Simulation training

Interventions

Simulation training OTHER

It is not a randomized trial - all three groups are exposed to simulation training.

Experienced; Intermediates; Novice

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen Academy for Medical Education and Simulation: collaborator

Study Sites (2)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Danmark, 2100, Denmark

Location

Urology Department, Zealand University Hospital

Roskilde, DK-4000, Denmark

Location

Related Publications (17)

• 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.

  PMID: 26003818 BACKGROUND

• 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.

  PMID: 27045233 BACKGROUND

• 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.

  PMID: 25412849 BACKGROUND

• 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.

  PMID: 19219610 BACKGROUND

• 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.

  PMID: 24286506 BACKGROUND

• 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.

  PMID: 19524354 BACKGROUND

• 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.

  PMID: 22357009 BACKGROUND

• 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. doi: 10.1055/s-2007-1001366.

  PMID: 9826140 BACKGROUND

• 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.

  PMID: 22044434 BACKGROUND

• 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. No abstract available.

  PMID: 19035888 BACKGROUND

• 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.

  PMID: 22313727 BACKGROUND

• Miladi M, Peyromaure M, Zerbib M, Saighi D, Debre B. The value of a second transurethral resection in evaluating patients with bladder tumours. Eur Urol. 2003 Mar;43(3):241-5. doi: 10.1016/s0302-2838(03)00040-x.

  PMID: 12600426 BACKGROUND

• 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.

  PMID: 28753839 BACKGROUND

• Nayahangan LJ, Bolling 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.

  PMID: 28743217 BACKGROUND

• 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.

  PMID: 26148761 BACKGROUND

• 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.

  PMID: 27549358 BACKGROUND

• 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.

  PMID: 22691145 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D. student

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: March 15, 2018
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)