Development and Validation of a Simulator-based Test in Transurethral Resection of Bladder Tumors

March 4, 2019 updated by: Sarah Hjartbro Bube, Rigshospitalet, Denmark

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence of bladder tumors is increasing and is more than 2,000 in Denmark. The bladder tumor is initially treated by transurethral resection (TURB) classifying the tumor by debt of invasion. The bladder wall is composed of urothelium, lamina propria and muscularis propria also known as the detrusor muscle. Bladder cancer (BC), defined as detrusor-muscle invasive tumors, are found in approximately 50% of bladder tumors. BC is the seventh most common cancer disease among men worldwide, and the fourth most common cancer in men in Denmark. Superficial bladder tumors can be treated with TURB whereas BC is treated with radical cystectomy. Thus, it is of utmost importance that TURB is done with sufficient resection of the detrusor muscle to ensure that the patient is staged correctly to optimise treatment.

TURB was first described and performed by Desormeaux in 1867 and the obstacles for the surgeon remain the same more the 150 years after. TUR-B demands haptic skills, the ability to identify the layers of the bladder wall, the ability to perceive the stiffness of the tissue through radial and tangential movements and the ability to translate two-dimensional pictures to a three-dimensional understanding and at the same time move surgical instruments around an axis.

As TUR-B is performed through the urethra with one scope only, the learner is left with observation of the master until the day occurs where the learner is trusted the scope. Thus, the gap between seeing and doing TURB remains significant.

The outcome of TURB have been shown to be dependent on surgeon-experience, with a higher risk for insufficient resections with lower surgeon experience. A recent Canadian study from a single centre showed that resident involvement in TUR-B had fewer complete resections including the detrusor muscle layer in the pathological specimen and patients had delayed time to cystectomy when compared to patients who had the TUR-B performed by attending urologists. Thus, both patient safety and quality of care are compromised when residents are involved in the treatment and staging of patients with bladder tumors.

The current education in TURB in Denmark is based on classical apprenticeship as it has been for the last 150 years, with the resident learning from a supervisor while performing TURB on patients.

Needs assessment analyses among specialists in urology and medical education in Denmark in 2017 identified TURB as a procedure in which simulation based skill acquisition are desired.

Simulation-based training is increasingly used in medical education. The opportunity to train a procedure repeatedly in a secure, stress-free environment with several different scenarios is appealing. Even though simulation-based training carries these promising opportunities, the challenge, when introducing simulation-based training, is to identify if the training transfer to actually improved performance on patients. Thus, we need to test if the simulator training leads to a level of minimum competency before progressing to performance on patients. A minimum passing standard should not be defined by amount of training, but by simulator performance outcomes.

Thus, we need to define test outcomes that identify competency before introducing a simulation-based test. Mastery learning (ML) is an educational theory in which the learner is to train 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. In the light of the ML framework the principle of directed self-regulated learning (DSRL) has evoked. DSRL is a learning-approach where the student regulates his/her own progress through a defined training protocol without guidance from an instructor. The theory is that this approach provides the student the opportunity to develop own strategies and to learn from mistakes, while also increasing the availability of training independent of supervision from a busy faculty.(20) DSRL can be modified to ensure that the learner do not learn unappropriated methods by either written theoretical material, video instructions, a non-expert assistant or all of them. Thus, the purpose of this trial is to develop and gather validity evidence for a simulator-based test in TURB based on the principles of ML and DSRL.

Hypothesis Overall: A simulator-based test can identify competency-levels with regard to a score based simulator metrics.

Aim of project To develop and gather validity evidence for a simulator-based test in TURB.

Research Question

  • Can the test discriminate between varying competency levels?
  • Can we establish a level of competency by a test in simulator-based TURB training?

Study Type

Observational

Enrollment (Actual)

49

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
      • Roskilde, Denmark, DK-4000
        • Urology Department, Zealand University Hospital
    • Danmark
      • Copenhagen, Danmark, Denmark, 2100
        • Copenhagen Academy for Medical Education and Simulation

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Based on previous studies on TURB simulation and surgeon depending surgical outcomes, three groups are conducted: Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB, intermediary experienced senior residents defined as surgeons who have performed between 10 and 30 TURBs and consultants with expertise in the procedure defined as more than 100 TURBs.(6,16,21,22) Residents, intermediates, and consultants at the three Urological Departments of the Zealand Region and the Capital Region will be invited to voluntary participation by written invitation. All eligible doctors will be categorised in the three groups until the sample size is reached.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Novice
Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB
Other: Simulation training
It is not a randomized trial - all three groups are exposed to simulation training.
Intermediates
Residents who have performed 10 to 30 TURBs.
Other: Simulation training
It is not a randomized trial - all three groups are exposed to simulation training.
Experienced
Consultants with experience in the procedure defined as more than 100 TURBs.
Other: Simulation training
It is not a randomized trial - all three groups are exposed to simulation training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean test score
Time Frame: Through study completion, an average of 4 weeks
Based on simulator metrics with significant discriminatory ability between different experience levels, a test score is constructed.
Through study completion, an average of 4 weeks

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

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)

March 15, 2018

Primary Completion (ACTUAL)

September 21, 2018

Study Completion (ACTUAL)

September 21, 2018

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (ACTUAL)

March 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-000048

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.

Clinical Trials on Medical Education

Clinical Trials on Simulation training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe