Clinical trial NCT03087812: Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy
Official title: Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stones
Keywords: Microbiological burden
kidney
stone
durability of flexible endoscopes
Lead sponsor: Clinical Research Office of the Endourological Society
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population compromises those patients of over eighteen years old diagnosed to undergo a ureterorenoscopy (diagnostic or therapeutic) with a flexible ureterorenoscope.

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.

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:

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.

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).

Eligibility criteria: Inclusion Criteria:

* Patient presented with a diagnosis to undergo a ureterorenoscopy using a flexible ureterorenoscope
* over 18 years
* has signed informed consent
* the patient is being treated with the designated flexible ureterorenoscope

Primary outcomes:
measure: Microbiological load
timeFrame: 2 years
Secondary outcomes:
measure: Durability
timeFrame: 2 years
measure: Factors affecting durability
timeFrame: 2 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC University Hospital
Study officials:
affiliation: Clinical Research Office of the Endourological Society
name: Jean de la Rosette, MD, PhD
role: STUDY_CHAIR
References: