NCT01884870

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

June 19, 2013

Last Update Submit

June 2, 2015

Conditions

Urinary Calculi

Keywords

Asymptomaticureteralcalculirenal functiontreatment

Outcome Measures

Primary Outcomes (1)

  • Ipsilateral Renal Function

    Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.

    1 year

Secondary Outcomes (3)

  • Serum Creatinine level

    1 year

  • Estimated Creatinine Clearance

    1 year

  • Renal Anatomy assessed by Ultrasound

    1 year

Study Arms (1)

Surgical Treatment

OTHER

Silent Ureteral Stone - Surgical Treatment

Procedure: Surgical Treatment

Interventions

Surgical TreatmentPROCEDURE

Surgical Treatment - open, endoscopic or laparoscopic

Also known as: Surgical Treatment - open, endoscopic or laparoscopic
Surgical Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital - University of Sao Paulo Medical School

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Urinary CalculiCalculi

Interventions

Surgical Procedures, OperativeEndoscopyLaparoscopy

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical Procedures

Study Officials

  • Giovanni S Marchini, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni S Marchini, MD

CONTACT

55-11-98179-8186giovanni_marchini@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 24, 2013

Study Start

November 1, 2012

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

BR(1)