Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

NCT ID: NCT01884870

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-08-31

Brief Summary

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Ureteral stones may be silent in 5.3% of patients. The goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function.

Detailed Description

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The prevalence of nephrolithiasis is increasing worldwide, reaching 5.2% in North America and 10.1% in Italy. The widespread use of computed tomography and ultrasonography have resulted in a greater detection rate of asymptomatic stones and, in part, might explain the trend. Clinically, kidney or ureteral stones range in severity from asymptomatic to presenting with complete renal failure. Therefore, it is not only the alarming incidence of urinary stone disease, but also the associated burden that makes this one of the most concerning conditions in public health.

The situation becomes even more distressing when managing asymptomatic stones. Studies of the natural history of stones have revealed that only 20% of patients yearly actually become symptomatic from a new stone, and one half of those require surgical intervention at some point. The guidelines are well established for the treatment of symptomatic urolithiasis, and many investigators have extensively studied the management of silent kidney stones. Conversely, the same is not true for silent ureterolithiasis. The purpose of the present study is to report the investigators experience managing silent ureteral stones and to prospectively analyze their true influence on renal function.

Conditions

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Urinary Calculi

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Treatment

Silent Ureteral Stone - Surgical Treatment

Group Type OTHER

Surgical Treatment

Intervention Type PROCEDURE

Surgical Treatment - open, endoscopic or laparoscopic

Interventions

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Surgical Treatment

Surgical Treatment - open, endoscopic or laparoscopic

Intervention Type PROCEDURE

Other Intervention Names

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Surgical Treatment - open, endoscopic or laparoscopic

Eligibility Criteria

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Inclusion Criteria

* Silent ureteral stone: no subjective/objective symptoms related to the ureteral calculi.
* Patient willing to participate in the study
* Complete pre/post-operative work-up

Exclusion Criteria

* Treatment outside our institution
* No will to be a part of the study
* Incomplete pre/post-operative work-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Scala Marchini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni S Marchini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Clinics Hospital - University of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Giovanni S Marchini, MD

Role: CONTACT

55-11-98179-8186

Facility Contacts

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Eduardo Mazzucchi, PhD

Role: primary

55-11-26618080

Other Identifiers

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Online Number: 9015

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAAE: 01187012.2.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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