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临床试验/NCT03864302
NCT03864302Unknown不适用

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

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
试验地点
2
主要终点
OSATURB total score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

OSATURB total score

时间窗: 8 hours pr. participant

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Hjartbro Bube

Principal Investigator

Zealand University Hospital

研究点 (2)

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