Clinical trial · Interventional
Simulation in Transurethral Bladder Cancer Surgery
Effect of Motor-imagery in Simulator-based Training in Transurethral Resection of Bladder Tumors - a Randomized Trial
- 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 disease among men worldwide, and the fourth most common cancer in Danish men with an incidence of more than 2000 and a prevalence of 650 per 100000 citizens. BC have a poor prognosis even when treated radically with cystectomy. The 5-year survival rate after radical cystectomy for T2 muscle-invasive tumors are 23-60 % and decreasing further to 23 % for T4 muscle-invasive tumors. BC is highly recurrent with an overall recurrence of 50 %. BC is considered to be the number one cost-expensive malignant disease of all malignant diseases measured by lifetime per patient in the United States. The degree of muscle invasion in the bladder is histologically and clinically defined by a transurethral resection of the bladder tumor (TUR-B). The tumor is resected radically if possible. Thus, it is of absolute importance that a sufficient TURB is performed, since a resection to the muscle layer of the bladder wall, the detrusor, is of prognostic value for the patient. Problem: The quality of the surgery is depending on the surgeon A recent international meta-analysis shows that up to 78% of the tumors are not radically resected. When these tumors are resected in a second TURB 24-28% of the tumors are found to be muscle-invasive. Furter, there is evidence indicating that the outcome of the resection is dependent on surgeon experience. Large multi-centre retrospective studies have showed that resident-involvement in TURB results in less radical bladder tumor resections and result in higher recurrence rates of bladder tumors and high numbers of re-admission after TURB. In Denmark, the current surgical curriculum states that TURB is a learning goal in the first year of the training. The formal training in TURB in Denmark is traditional apprenticeship in accordance with the Halstedian principle "see one, do one, teach one". No validated simulator-based certification in TURB exits today in Denmark or internationally. Purpose: Start from the beginning - improve the training of the surgeons Simulator-based training in surgical procedures is an effective method to gain surgical skills in a large spectrum of surgical procedures. In the initial phase of the learning curve it has even proven more effective than traditional apprenticeship and thus both the World Health Organization (WHO) and the European Association of Urology (EAU) calls for implementation of simulation training programmes in medical surgical education. The aim of this project is to validate and develop a simulator-based urological training programme in TURB, to implement the programme nationally and internationally, and hereby improve the outcomes in the surgical treatment of patients with bladder cancer.
Conditions
Conditions (3)
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 |
| Education | — | UNRESOLVED | — |
| Virtual Reality | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Motor Imagery | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Motor Imagery
- description
- The intervention group is informed about the concept of motor imagery (MI) for performance enhancement and are instructed in using the modified PETTLEP framework for TURB (table 1).(18) The intervention group performs a MI training session (MITS) prior to each VR simulation procedure. Table 1: PEELP framework: Physical: Sitting in front of the simulator, aloud to touch and move the scope Environment: Simulated sounds from the OR, including electrical device feedback from devices and vital measures Task: Four standardized TURB cases Timing: Each MI session is temporal to a simulated TURB case, max. 10 minutes Learning: Think aloud the major steps of the procedure using Emotions: Imagine the emotions when the surgery progresses and when an adverse event occurs Perspectives: Internal perspective thinking "then I…"
- interventionNames
- Behavioral: Motor Imagery
- type
- NO_INTERVENTION
- label
- Control
- description
- The control group proceeds directly to standard VR-simulator training.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Doctors * Informed written consent. * Four video-recordings of TURBs. Exclusion Criteria: * Not providing four video recordings of TURB procedures * Simulation-based training course in TURB within 6 months * No consent
References
Publications (32)
- BACKGROUNDBirkmeyer JD, Finks JF, O'Reilly A, Oerline M, Carlin AM, Nunn AR, Dimick J, Banerjee M, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013 Oct 10;369(15):1434-42. doi: 10.1056/NEJMsa1300625. PMID 24106936
- BACKGROUNDBjerrum F, Thomsen ASS, Nayahangan LJ, Konge L. Surgical simulation: Current practices and future perspectives for technical skills training. Med Teach. 2018 Jul;40(7):668-675. doi: 10.1080/0142159X.2018.1472754. Epub 2018 Jun 17. PMID 29911477
- BACKGROUNDCook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234. PMID 21900138
- BACKGROUNDMcGaghie WC, Issenberg SB, Barsuk JH, Wayne DB. A critical review of simulation-based mastery learning with translational outcomes. Med Educ. 2014 Apr;48(4):375-85. doi: 10.1111/medu.12391. PMID 24606621
- BACKGROUNDMcGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med. 2011 Jun;86(6):706-11. doi: 10.1097/ACM.0b013e318217e119. PMID 21512370
- BACKGROUNDKonge L, Clementsen PF, Ringsted C, Minddal V, Larsen KR, Annema JT. Simulator training for endobronchial ultrasound: a randomised controlled trial. Eur Respir J. 2015 Oct;46(4):1140-9. doi: 10.1183/13993003.02352-2015. Epub 2015 Jul 9. PMID 26160875
- BACKGROUNDBorgersen NJ, Naur TMH, Sorensen SMD, Bjerrum F, Konge L, Subhi Y, Thomsen ASS. Gathering Validity Evidence for Surgical Simulation: A Systematic Review. Ann Surg. 2018 Jun;267(6):1063-1068. doi: 10.1097/SLA.0000000000002652.