OSATURB: Simulation in Transurethral Bladder Cancer Surgery

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03864302

Collaborator

Copenhagen Academy for Medical Education and Simulation (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality Education Bladder Cancer	Behavioral: Motor Imagery	N/A

Detailed Description

Doctors' surgical skills have consequences for patients outcomes and continued training and assessment of surgeons has the potential to improve patient safety and shorten learning curves in the operation room.

Traditionally, surgeons have acquired their skills by observation, supervision and direction of masters in the field. Such education is indispensable. Only, with the increasing demands on production, patient safety issues and decreasing working hours a need for alternatives to the classical surgical training has awoken.

Simulated surgeries make it possible to repeat and perfect performances until reaching a proficient level. Virtual reality (VR) simulators can provide continuously automated feedback while the doctor is performing the procedure and thus direct the training.

Thus, in the last decades simulators for surgical skills training have gained increasing popularity. Simulation training has been found efficient in skills acquisition in a variety of surgical procedures.Simulators allow repeating training until reaching a proficiency level in the skill. Ultimately, the doctor reaches a minimum competent skill acquisition in the procedure prior to advancing to surgeries on patients.

Mastery Learning (ML) is a strict proficiency training concept, in which the learner trains 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. Hence, ML ensures a minimum skill acquisition level.

In the initial learning phase of the learning curve the use of ML simulation training has been proven superior to traditional apprenticeship.

To identify proficiency, assessments are needed. The assessments should be based on solid evidence of validity. The development and validation of tests are essential in a proficiency-based curriculum.

Constructing a training curriculum in surgery should be based on a defined framework. Zevin et al. proposed a training-design framework composed of three steps: cognitive knowledge (conceptualization, visualization and verbalization), psychomotor skills training (deliberate and distributed self-regulated training to a targeted proficiency-level, with continuing feedback and maintenance) and non-technical skills (communication, collaboration, professionalism and management). Thomas et al. proposed a six-step approach for curriculum development including problem identification, need assessment, goal setting and teaching objectives, educational strategies, implementation and evaluation and feedback.

A needs assessment analysis among residents and urologists in Denmark from 2017 confirms the feasibility and necessity of comprehensive ex-vivo simulation-based curriculum in TUR-B. TUR-B simulators have been available for a decade but some have proven insufficiency, others promising, but there is a need for creation of evidence-based simulator training programs and development of valid assessments tool to evaluate the performances.

The effect on training of a novel curriculum can be explored and evaluated using a framework such as Kirkpatrick's model for evaluation of training effect on skills, transfer from simulation to workplace, benefits for patients, and finally economics and return of investments.

This trial aims to develop an evidence-based TURB training and certification program including an assessment tool for clinical procedures (trial 1.1), learning curve study (trial 1.2) and pre- and post-training study and effects on operation room TURB performance (trial 1.3) and explore the prognostic clinical value of performance on simulation-based test (trial 1.4).

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Effect of Motor-imagery in Simulator-based Training in Transurethral Resection of Bladder Tumors - a Randomized Trial

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Mar 30, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motor Imagery 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 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)
No Intervention: Control The control group proceeds directly to standard VR-simulator training.

Arm

Intervention/Treatment

Experimental: Motor Imagery

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

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)

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

OSATURB total score [8 hours pr. participant]
Assessment tool with nine items, each item i rated on a 5-point Likert scale, minimum of 1, max. 5.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Department Zealand University Hospital	Roskilde	Danmark	Denmark	4000

Sponsors and Collaborators

Rigshospitalet, Denmark
Copenhagen Academy for Medical Education and Simulation

Investigators

Principal Investigator: Sarah Bube, MD, Zeland Region

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Sarah Hjartbro Bube, Principal Investigator, Zealand University Hospital

ClinicalTrials.gov Identifier:

NCT03864302

Other Study ID Numbers:

H-19-1-OSATURB

First Posted:

Mar 6, 2019

Last Update Posted:

Aug 24, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Aug 24, 2021