Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney

Study Overview
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Brief Summary
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Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have small kidney stones that don't cause symptoms. If these small kidney stones are determined to be asymptomatic (not causing any problems or pain), then most urologists will simply remove the symptomatic ureteral stone and leave the additional stones in the kidneys. However, symptomatic kidney stones started as small stones that didn't cause symptoms. This means that the small stones remaining in the patient's kidney may cause problems later. The purpose of our research is to test if removing small stones from the kidney prevents future stone episodes.

Official Title
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Randomized Controlled Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney

Conditions
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Ureteral Stones, Kidney Stones

Intervention / Treatment
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* Procedure: Symptomatic stone removal
* Procedure: Asymptomatic kidney stones and ureteral stone removed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo surgery (URS or PCNL) for a primary stone. Computed tomography (CT) exam within the 90-day pre-operative period Small (≤ 6mm) asymptomatic stones in visible on KUB or CT (i.e., calcium stones) in the contralateral kidney for a primary renal stone or ipsilateral kidney for primary ureteral stone. Recurrent (having had previous stones) or multiple (simultaneous bilateral stones) stones Able to give informed consent Age 21 years or older Exclusion Criteria: Inability to give informed consent Age less than 21 years Stones not visible on KUB or CT Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney) Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. Unwilling to participate.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Symptomatic stone removal<br>Group 1 will receive the standard treatment of having only the symptomatic stone removed | Procedure: Symptomatic stone removal<br>* Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy<br>|
| Other: Asymptomatic kidney stones and symptomatic stone removed<br>Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone | Procedure: Asymptomatic kidney stones and ureteral stone removed<br>* Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of stone disease on the study side | Radiological evidence of significant growth in the size of any pre-existing stone Return for stone removal surgery on the study side Passage of a stone with pain symptoms on the study side resulting in an emergency department visit | annually up to 5 years after stone removal surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney stone