Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy

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.

Study Overview

• Status: Completed
• Conditions: Kidney Stones

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).

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • AMC University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological load	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability	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.	2 years
Factors affecting durability	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.	2 years

Collaborators and Investigators

• Sponsor: Clinical Research Office of the Endourological Society

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: kidney; stone; Microbiological burden; durability of flexible endoscopes
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi
• Other Study ID Numbers: NL201501