Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy
Study Details
Study Description
Brief Summary
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the ureteroscopes and the possible microbiological load.
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Detailed Description
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 6 new ureteroscopes are used (3 from Olympus and 3 from Storz) to study the durability of the ureteroscopes and the possible microbiological load.
Before the procedure is started the endoscope is tested for its microbiological load in two different ways:1. Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.
After the procedure is finished, the endoscope is tested for its microbiological load in two different ways:
- Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.
Transfer all samples to the lab as soon as possible but at least within four hours after collecting the samples.
As for the clinical efficacy during each procedure a detailed questionnaire about the use of each ureteroscope is filled out. This includes the ease of use making mention on quality of the image, torque, flexibility and durability.
Data will be collected through electronic case report forms (eCFRs), with use of an online Data Management system (DMS).
Study Design
Outcome Measures
Primary Outcome Measures
- Microbiological load [2 years]
To evaluate the pre-operative microbiological load of the tip and the working channel of the most common used flexible ureteroscopes, after high level disinfection
Secondary Outcome Measures
- Durability [2 years]
To evaluate the durability of the most common used flexible ureteroscopes in terms of number of procedures, total use time and total degrees of flexibility loss until the first repair is needed.
- Factors affecting durability [2 years]
To evaluate descriptive data on factors that may affect the durability of the flexible ureteroscopes. Factors measured are treatment time, treatment indication and anatomical location in the urinary tract, method of ureteroscope insertion number and type of accessory instrumentation through the working channel, difference in users, number of forcing the scope during the procedure and the number of disinfections.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient presented with a diagnosis to undergo a ureterorenoscopy using a flexible ureterorenoscope
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over 18 years
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has signed informed consent
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the patient is being treated with the designated flexible ureterorenoscope
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | AMC University Hospital | Amsterdam | Netherlands | 1105AZ |
Sponsors and Collaborators
- Clinical Research Office of the Endourological Society
Investigators
- Study Chair: Jean de la Rosette, MD, PhD, Clinical Research Office of the Endourological Society
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL201501