Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy

NCT ID: NCT02739919

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-02-24

Brief Summary

The aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. It is well known that struvite stones are associated with active bacterial infection, however the role of bacteria in the formation of non-infection stones (like calcium oxalate) is not well characterized and there are theories that bacteria are involved in the making of these stones.

Detailed Description

Kidney stone disease is common, affecting nearly 10% of the population with increasing prevalence and increasing cost associated to treat this disease. While struvite stones (composed of magnesium, ammonium and phosphate crystals) have been associated with the presence of infection, the association between bacteria and non-infection stones is not well characterized. Previous studies have found bacteria present in stones of patients without active infection and with negative pre-operative urine tests.

There are various compositions of kidney stones, including calcium oxalate, calcium phosphate, struvite and uric acid, with calcium oxalate being the most common. It is well known that struvite stones are associated with active infection, however the role of bacteria in the formation of other types of kidney stones, including calcium oxalate, is not well understood. The investigators hypothesize that bacteria present in the urinary tract of patients without active infection have the ability to facilitate calcium oxalate crystal formation by providing a surface for stones to grow. An understanding of the role of bacteria in the formation of non-infection stones could help prevent stone formation by altering the bacteria present within patients to decrease or eliminate their risk of kidney stone disease.

Conditions

Urolithiasis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Over the age of 18
• Diagnosed with or have a high index of suspicion of having a kidney stone and scheduled to undergo percutaneous nephrolithotomy.
• Medically fit for definitive surgical management of stone

Exclusion Criteria

• Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
• Patients who are unable to provide informed consent.
• 18 years old or younger
• Diagnosed with an infection stone
• Urinary tract infection within 3 months before date of operation
• Antibiotic use within 3 month before date of operation

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Dirk Lange

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk Lange, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Ben H Chew, MD

Role: STUDY_DIRECTOR

University of British Columbia

Locations

The Stone Centre, VGH/UBC

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H16-00637

Identifier Type: -

Identifier Source: org_study_id