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

NCT ID: NCT03863028

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2018-09-21

Brief Summary

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).

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?

Conditions

Validity-evidence for a Simulator-based Test; Virtual Simulation; Bladder Cancer; Surgical Skill Training; Medical Education; Transurethral Resection of Bladdertumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Novice

Residents with no individual experience in TUR-B defined as no prior hands-on surgical experience in TURB

Simulation training

Intervention Type: OTHER

It is not a randomized trial - all three groups are exposed to simulation training.

Intermediates

Residents who have performed 10 to 30 TURBs.

Simulation training

Intervention Type: OTHER

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.

Simulation training

Intervention Type: OTHER

It is not a randomized trial - all three groups are exposed to simulation training.

Interventions

Simulation training

It is not a randomized trial - all three groups are exposed to simulation training.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Copenhagen Academy for Medical Education and Simulation

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Sarah Hjartbro Bube

MD, Ph.D. student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Danmark, Denmark

Urology Department, Zealand University Hospital

Roskilde, , Denmark

Countries

Denmark

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Other Identifiers

17-000048

Identifier Type: -

Identifier Source: org_study_id