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Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Giovanni Scala Marchini, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Giovanni Scala Marchini, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01884870
First received: June 19, 2013
Last updated: June 2, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention
Urinary Calculi Procedure: Surgical Treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Silent Ureteral Stone on Renal Function and Kidney Anatomy: a Prospective Analysis

Resource links provided by NLM:


Further study details as provided by Giovanni Scala Marchini, University of Sao Paulo:

Primary Outcome Measures:
  • Ipsilateral Renal Function [ Time Frame: 1 year ]
    Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.


Secondary Outcome Measures:
  • Serum Creatinine level [ Time Frame: 1 year ]
    Serum Creatinine level

  • Estimated Creatinine Clearance [ Time Frame: 1 year ]
    Estimated Creatinine Clearance

  • Renal Anatomy assessed by Ultrasound [ Time Frame: 1 year ]
    Renal Anatomy assessed by Ultrasound


Estimated Enrollment: 25
Study Start Date: November 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgical Treatment
Silent Ureteral Stone - Surgical Treatment
Procedure: Surgical Treatment
Surgical Treatment - open, endoscopic or laparoscopic
Other Name: Surgical Treatment - open, endoscopic or laparoscopic

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884870

Contacts
Contact: Giovanni S Marchini, MD 55-11-98179-8186 giovanni_marchini@yahoo.com.br

Locations
Brazil
Clinics Hospital - University of Sao Paulo Medical School Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Eduardo Mazzucchi, PhD    55-11-26618080    mazuchi@terra.com.br   
Principal Investigator: Giovanni S Marchini, MD         
Sub-Investigator: Eduardo Mazzucchi, PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Giovanni S Marchini, MD University of Sao Paulo
  More Information

Responsible Party: Giovanni Scala Marchini, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01884870     History of Changes
Other Study ID Numbers: CAAE: 01187012.2.0000.0068
Online Number: 9015 ( Registry Identifier: Online Number: 9015 )
Study First Received: June 19, 2013
Last Updated: June 2, 2015

Keywords provided by Giovanni Scala Marchini, University of Sao Paulo:
Asymptomatic
ureteral
calculi
renal function
treatment

Additional relevant MeSH terms:
Calculi
Ureteral Calculi
Ureterolithiasis
Urinary Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis

ClinicalTrials.gov processed this record on June 23, 2017