Simulation in Transurethral Bladder Cancer Surgery (OSATURB)

August 23, 2021 updated by: Sarah Hjartbro Bube, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Roskilde, Danmark, Denmark, 4000
        • Urology Department Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSATURB total score
Time Frame: 8 hours pr. participant
Assessment tool with nine items, each item i rated on a 5-point Likert scale, minimum of 1, max. 5.
8 hours pr. participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Copenhagen Academy for Medical Education and Simulation

Investigators

  • Principal Investigator: Sarah Bube, MD, Zeland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

March 30, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19-1-OSATURB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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