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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02411747
• Collaborator: (none)
• Enrollment: 32
• Arms: 2
• Duration (Months): 5.9

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Aug 1, 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 [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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Sarah Hjartbro Bube, Medical Doctor, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02411747
• Other Study ID Numbers: H-4-2014-122
• First Posted: Apr 8, 2015
• Last Update Posted: Jul 22, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Sarah Hjartbro Bube, Medical Doctor, Rigshospitalet, Denmark: Medical; Urology; Randomized Controlled Trial; Endoscopy; Cystoscopy

Study Results

Participant Flow

Arm/Group Title	Directed Self-regulated Simulation Training+Testing	Oral Lecture+Simulation Training
Arm/Group Description	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 an expert in the procedure. Total max time: 2 hours. Directed self-regulated simulation training Testing	Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours. Oral expert lecture Simulation training
Period Title: Overall Study
STARTED	16	16
Simulation Training Completed	16	16
COMPLETED	13	12
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Directed Self-regulated Simulation Training+Testing	Oral Lecture+Simulation Training	Total
Arm/Group Description	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. Directed self-regulated simulation training Testing	Endoscopic training in flexible cystoscopy by simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours. Oral expert lecture Simulation training	Total of all reporting groups
Overall Participants	16	16	32
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	16 100%	32 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	26	26	26
Sex: Female, Male (Count of Participants)
Female	13 81.3%	11 68.8%	24 75%
Male	3 18.8%	5 31.3%	8 25%
Future interest for surgical specility (participants) [Number]
Surgical	10 62.5%	9 56.3%	19 59.4%
Not surgical/not desided	6 37.5%	7 43.8%	13 40.6%

Outcome Measures

1. Primary Outcome

Title	Global Rating Scale
Description	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.
Time Frame	Two to four weeks after day of simulation training

Outcome Measure Data

Analysis Population Description

Two cystoscopies performed on patients by each participant

Arm/Group Title	Directed Self-regulated Simulation Training+Testing	Oral Lecture+Simulation Training
Arm/Group Description	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 an expert in the procedure. Total max time: 2 hours. Directed self-regulated simulation training Testing	Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours. Oral expert lecture Simulation training
Measure Participants	13	12
Measure Number cystoscopies	26	24
Mean (Standard Deviation) [units on a scale]	13.6 (4.2)	13.4 (3.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Directed Self-regulated Simulation Training+Testing, Oral Lecture+Simulation Training
	Comments	Independent samples t-test
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Beta: 0.8, p significant if p > 0.005
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Directed Self-regulated Simulation Training+Testing		Oral Lecture+Simulation Training
Arm/Group Description	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 an expert in the procedure. Total max time: 2 hours. Directed self-regulated simulation training Testing		Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours. Oral expert lecture Simulation training
All Cause Mortality
	Directed Self-regulated Simulation Training+Testing		Oral Lecture+Simulation Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Directed Self-regulated Simulation Training+Testing		Oral Lecture+Simulation Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Directed Self-regulated Simulation Training+Testing		Oral Lecture+Simulation Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.