Simulation in Transurethral Bladder Cancer Surgery

NCT03864302 | Unknown DMC

• 1 other identifier: H-19-1-OSATURB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Virtual Reality; Education; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• OSATURB total score

  Assessment tool with nine items, each item i rated on a 5-point Likert scale, minimum of 1, max. 5.

  8 hours pr. participant

Study Arms (2)

Motor Imagery

EXPERIMENTAL

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…"

Behavioral: Motor Imagery

Control

NO INTERVENTION

The control group proceeds directly to standard VR-simulator training.

Interventions

Motor Imagery BEHAVIORAL

Motor imagery (MI) is a psychological technique for improvement of motor skills.(24) MI skill training (MIST) has been used and explored in several disciplines including Sports, Music, Education, Psychology and Medicine.(18) The literature has found positive effects on performances in professional athletes but also on rehabilitation of stroke patients.(25,26) MI is a cognitive imagery of a physical performance, e.g. a high jumper imagine a high jump, prior to performance. MI is not as effective as physical practice, but more effective compared to no training.(27) Further, MI combined with physical practice has been found to be more effective in skill performance in sports compared to physical practice alone.(18) MIST has shown promising results on surgical performances in flexible cystoscopy performed by doctors.(28)

Motor Imagery

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Doctors
• Informed written consent.
• Four video-recordings of TURBs.

You may not qualify if:

• Not providing four video recordings of TURB procedures
• Simulation-based training course in TURB within 6 months
• No consent

Sponsors & Collaborators

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

Study Sites (1)

Urology Department Zealand University Hospital

Roskilde, Danmark, 4000, Denmark

Location

Related Publications (32)

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  BACKGROUND

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  BACKGROUND

• Bube SH, Kingo PS, Madsen MG, Vasquez JL, Norus T, Olsen RG, Dahl C, Hansen RB, Konge L, Azawi N. National Implementation of Simulator Training Improves Transurethral Resection of Bladder Tumours in Patients. Eur Urol Open Sci. 2022 Apr 1;39:29-35. doi: 10.1016/j.euros.2022.03.003. eCollection 2022 May.

  PMID: 35528788 DERIVED

• Bube SH, Kingo PS, Madsen MG, Vasquez JL, Norus T, Olsen RG, Dahl C, Hansen RB, Konge L, Azawi N. Validation of a Novel Assessment Tool Identifying Proficiency in Transurethral Bladder Tumor Resection: The OSATURBS Assessment Tool. J Endourol. 2022 Apr;36(4):572-579. doi: 10.1089/end.2021.0768.

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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 Officials

• Sarah Bube, MD

  Zeland Region

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 6, 2019
• Study Start: June 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: December 31, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)