Clinical trial · Observational
Development and Validation of a Simulator-based Test in Transurethral Resection of Bladder Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Medical Education | — | UNRESOLVED | — |
| Surgical Skill Training | — | UNRESOLVED | — |
| Transurethral Resection of Bladdertumors | Bladder Neoplasm | PROBABILISTIC | 0.70 |
| Validity-evidence for a Simulator-based Test | — | UNRESOLVED | — |
| Virtual Simulation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simulation training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Novice
- description
- Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB
- interventionNames
- Other: Simulation training
- label
- Intermediates
- description
- Residents who have performed 10 to 30 TURBs.
- interventionNames
- Other: Simulation training
- label
- Experienced
- description
- Consultants with experience in the procedure defined as more than 100 TURBs.
- interventionNames
- Other: Simulation training
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (17)
- BACKGROUNDAllard 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
- BACKGROUNDBos 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
- BACKGROUNDAmin 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
- BACKGROUNDPloeg 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
- BACKGROUNDJancke 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
- BACKGROUNDMariappan 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.