Protocol summary

Summary
In this study, we are intending to compare two surgical methods (ESWL and TUL) for the treatment of pediatric lower ureteral stones. 50 children below the age of 13 years with lower urethral stones and without ureteral anomaly or untreated coagulopathy who were referred to Shahid Labbafinejad Hospital will participate in this study to undergo Extracorporeal Shockwave Lithotripsy or Transurethral Lithotripsy through a multicentre randomized clinical trial. We compare two interventions kinds of surgery regarding becoming stone-free (effective factors on the treatment outcome such as size, number, location, and density of stone), the need for repeating the treatment, rate of minor complications (including inserting ureteral stents, nephrostomy,….), the rate of minor surgical complications such as pain, hematuria, UTI, steinstrasse, and major complications (ureteral perforation, detachment or stenosis, septicemia, non-functional kidney), and the patient’s and family’s satisfaction. Patients are followed up through physical examination, IVP and sonography up to 3 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138707021267N1
Registration date: 2009-08-30, 1388/06/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-08-30, 1388/06/08
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.(SBMU), Tehran, I.R.Iran
Expected recruitment start date
2008-10-06, 1387/07/15
Expected recruitment end date
2010-02-18, 1388/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The safety and efficacy of Extracorporeal Shockwave Lithotripsy versus Transureteral Lithotripsy for the treatment of pediatric lower ureteral stones: a multicentric randomized clinical trial
Public title
The safety and efficacy of Extracorporeal Shockwave Lithotripsy versus Transureteral Lithotripsy for the treatment of pediatric lower ureteral stones: a multicentric randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age less than 13 years, presence of lower urethral stones Exclusion criteria: History of previous urethral surgery, Ureteral anomaly, UTI, Untreated coagulopathy
Age
From 1 year old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urology and Nephrology Research Center (SBMU)
Street address
Urology and Nephrology Research center, No44, 9th Boostan St., Pasdaran Ave.,Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Approval date
2008-02-05, 1386/11/16
Ethics committee reference number
88

Health conditions studied

1

Description of health condition studied
lower ureteral stone
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter

Primary outcomes

1

Description
pain after surgery
Timepoint
up to 3 months
Method of measurement
Asking the patient

2

Description
hematuria
Timepoint
up to 3 months
Method of measurement
Asking the patient

3

Description
incidence of urinary tract infection
Timepoint
up to 3 months
Method of measurement
urinary culture

Secondary outcomes

1

Description
perforation of ureter
Timepoint
After surgery
Method of measurement
sonography and IVP

2

Description
stenosis of ureter
Timepoint
After surgery
Method of measurement
sonography and IVP

3

Description
incidence of septicemia
Timepoint
After surgery
Method of measurement
Blood culture

4

Description
Incidence of non-functional kidney
Timepoint
After surgery
Method of measurement
sonography and IVP

Intervention groups

1

Description
ESWL
Category
Treatment - Other

2

Description
TUL
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Labbafinejad Medical Center
Full name of responsible person
Dr. Sohrabpoor
Street address
9th Boostan, Pasdaran Ave.,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology and Nephrology Research center (SBMU)
Full name of responsible person
Shabnam Golshan
Street address
Urology and Nephrology Research center, No44, 9th Boostan, Pasdaran Ave.,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and Nephrology Research center (SBMU)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Urology and Nephrology Research center
Full name of responsible person
Dr. Samad Zare
Position
Resident of urology
Other areas of specialty/work
Street address
Urology and Nephrology Research center, No44, 9th Boostan, Pasdaran Ave.,Tehran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
basiri@unrc.ir
Web page address
www.unrc.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urology and Nephrology Research center
Full name of responsible person
Dr Abbas Basiri
Position
professor
Other areas of specialty/work
Street address
Urology and Nephrology Research center, No44, 9th Boostan, Pasdaran Ave.,Tehran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
research@unrc.ir
Web page address
www.unrc.ir

Person responsible for updating data

Contact
Name of organization / entity
Urology and Nephrology Research center
Full name of responsible person
Dr. Afagh Zarei
Position
General Physician
Other areas of specialty/work
Street address
Urology and Nephrology Research center, No44, 9th Boostan, Pasdaran Ave.,Tehran,
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
research@unrc.ir
Web page address
www.unrc.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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