Trial Outcomes & Findings for Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial (NCT NCT02411747)

Last Updated: 2019-07-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Two to four weeks after day of simulation training

Results posted on

2019-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Directed Self-regulated Simulation Training+Testing 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	Oral Lecture+Simulation Training 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
Overall Study STARTED	16	16
Overall Study Simulation Training Completed	16	16
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Directed Self-regulated Simulation Training+Testing 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	Oral Lecture+Simulation Training 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
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	2	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Directed Self-regulated Simulation Training+Testing n=16 Participants 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	Oral Lecture+Simulation Training n=16 Participants 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 n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	26 years n=93 Participants	26 years n=4 Participants	26 years n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	11 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Future interest for surgical specility Surgical	10 participants n=93 Participants	9 participants n=4 Participants	19 participants n=27 Participants
Future interest for surgical specility Not surgical/not desided	6 participants n=93 Participants	7 participants n=4 Participants	13 participants n=27 Participants

PRIMARY outcome

Timeframe: Two to four weeks after day of simulation training

Population: Two cystoscopies performed on patients by each participant

Outcome measures

Outcome measures
Measure	Directed Self-regulated Simulation Training+Testing n=26 Number cystoscopies 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	Oral Lecture+Simulation Training n=24 Number cystoscopies 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
Global Rating Scale	13.6 units on a scale Standard Deviation 4.2	13.4 units on a scale Standard Deviation 3.4

Adverse Events

Directed Self-regulated Simulation Training+Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Lecture+Simulation Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Bube, director of the CYSTOSIM project

Copenhagen Academy for Medical Education and Simulation, Rigshospitalet, Copenhagen University Hospital

Phone: +4561339183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place