Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial

• ClinicalTrials.gov Identifier: NCT02411747
• Recruitment Status: Completed
• First Posted: April 8, 2015
• Results First Posted: June 15, 2016
• Last Update Posted: July 22, 2019
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): Sarah Hjartbro Bube, Rigshospitalet, Denmark

Study Description

Brief Summary:

Simulation training in surgical education in Urology specialist training in flexible cystoscopy has been demonstrated a valid and efficient learning instrument. The classical setup with a medical expert introducing the novices to the theoretical background and technics of the procedure is time-consuming and expensive. Directed self-regulated simulation training (DSR) is a validated method in simulation training. The power of testing in DSR and flexible cystoscopy is to our knowledge not known. We introduced a setup in which the novices started by training in a directed self-regulated simulation training environment and informed them that they would be tested by a medical expert afterwards. The intervention group novices were given only written theoretical information and anatomical pictures. The control group were first given a classical oral theoretical introduction by a medical expert and secondly did DSR training. We tested the outcome of the intervention by a validated rating scale for flexible cystoscopy. The novices in both the control and intervention group were tested on patients prescribed a flexible cystoscopy and evaluated by a specialist in Urology.

The main hypothesis was that testing in relation to DSR would result in higher scores on a validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist in Urology compared to a group having a oral lecture before DSR.

Condition or disease	Intervention/treatment	Phase
Education	Behavioral: Testing; Behavioral: Directed self-regulated simulation training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial
• Study Start Date: February 2015
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Testing+endoscopic simulation training; Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours.	Behavioral: Testing; Behavioral: Directed self-regulated simulation training
Active Comparator: Oral lecture+endoscopic simulation training; Endoscopic training in flexible cystoscopy by directed self-regulated training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours.	Behavioral: Directed self-regulated simulation training

Outcome Measures

Primary Outcome Measures :

1. Global Rating Scale [ Time Frame: Two to four weeks after day of simulation training ]
   The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale. A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures. GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure. Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25. At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Senior medical students
• Novices in endoscopic procedures
• Written and oral consent

Exclusion Criteria:

• Performed a endoscopic procedure independently
• Lack of language skills
• Lack of written and oral consent

Contacts and Locations

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

• Principal Investigator: Sarah H. Bube, Cand.med.; Rigshospitalet, Denmark

More Information

Publications:

Matsumoto ED, Hamstra SJ, Radomski SB, Cusimano MD. A novel approach to endourological training: training at the Surgical Skills Center. J Urol. 2001 Oct;166(4):1261-6.

Schout BM, Ananias HJ, Bemelmans BL, d'Ancona FC, Muijtjens AM, Dolmans VE, Scherpbier AJ, Hendrikx AJ. Transfer of cysto-urethroscopy skills from a virtual-reality simulator to the operating room: a randomized controlled trial. BJU Int. 2010 Jul;106(2):226-31; discussion 231. doi: 10.1111/j.1464-410X.2009.09049.x. Epub 2009 Nov 12.

Kromann CB, Jensen ML, Ringsted C. The effect of testing on skills learning. Med Educ. 2009 Jan;43(1):21-7. doi: 10.1111/j.1365-2923.2008.03245.x.

Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.

Persoon MC, Schout BM, Muijtjens AM, Hendrikx AJ, Witjes JA, Scherpbier AJ. The effect of a low-fidelity model on cystoscopic skill training: a single-blinded randomized controlled trial. Simul Healthc. 2010 Aug;5(4):213-8. doi: 10.1097/SIH.0b013e3181e1b73d.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bube S, Dagnaes-Hansen J, Mahmood O, Rohrsted M, Bjerrum F, Salling L, Hansen RB, Konge L. Simulation-based training for flexible cystoscopy - A randomized trial comparing two approaches. Heliyon. 2020 Jan 3;6(1):e03086. doi: 10.1016/j.heliyon.2019.e03086. eCollection 2020 Jan.

• Responsible Party: Sarah Hjartbro Bube, Medical Doctor, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02411747
• Other Study ID Numbers: H-4-2014-122
• First Posted: April 8, 2015
• Results First Posted: June 15, 2016
• Last Update Posted: July 22, 2019
• Last Verified: July 2019

Keywords provided by Sarah Hjartbro Bube, Rigshospitalet, Denmark:

Medical; Urology; Randomized Controlled Trial; Endoscopy; Cystoscopy