Results of early pyeloplasty and maintenance therapy in asymptomatic infants with grade III and IV ureteropelvic junction obstruction (UPJO)
Design
Patients will be randomly divided into two groups and therapeutic results of each group will be evaluated.
Settings and conduct
The location of the study is in the Mofid children's hospital of Tehran. All surgeries are performed by a single surgery team and a type of surgery is approved by the surgeons of this centre.
Participants/Inclusion and exclusion criteria
All asymptomatic children under the age of one year with ureteropelvic junction obstruction ( UPJO) (grade 3 or 4 hydronephroses) proven with ultrasound and their differential renal function (DRF) based on the results of isotope scans should be least 40% or higher
Intervention groups
Asymptomatic children under the age of one who has UPJO Grade 3 and Grade 4. After obtaining a consent form, will randomly be divided into two groups, the first group will be treated non-surgically, and the second group will be assigned early Pyeloplasty Then, during a one-year period, patients will be monitored by urine analysis ultrasound and isotope scans.
Main outcome variables
The degree of ureteropelvic junction obstruction
General information
Reason for update
Acronym
UPJO
IRCT registration information
IRCT registration number:IRCT20180310039030N1
Registration date:2019-02-19, 1397/11/30
Registration timing:retrospective
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Khashayar Atqiaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3891 8707
Email address
khashayar_atqiaee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Results of early pyeloplasty and maintenance therapy in asymptomatic infants with grade III and IV ureteropelvic junction obstruction(UPJO)
Public title
Comparison of Surgical and non-surgical therapies in Infants with ureteropelvic junction obstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All asymptomatic children under one year of age with ureteropelvic junction obstruction (UPJO) (grade 3 or 4 hydronephroses)
The kidney differential function (DRF) is based on the results of isotope scans at least 40% or higher.
Exclusion criteria:
All children under one year of age with ureteropelvic junction obstruction( UPJO ) with symptoms such as urinary tract infections, palpable kidney pain
The presence of ureteral and kidney anomalies
Ultrasonography represents structural anomalies
voiding cystourethrogram (VCUG) represents urinary reflux and posterior urethral valve (PUV)
Age
From 1 month old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Patients are randomly assigned to one of the two intervention and follow-up groups based on the last digit of the case file. Persons with even numbers categorise as the intervention group and the persons with odd numbers categorise in the follow-up group.
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Mofid children Hospital, Shariati Ave
City
Tehran
Province
Tehran
Postal code
15468- 155514
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SBMU.MSP.REC.1397.590
Health conditions studied
1
Description of health condition studied
Ureteropelvic Junction Obstruction
ICD-10 code
N13.1
ICD-10 code description
Hydronephrosis with ureteropelvic junction obstruction
Primary outcomes
1
Description
The degree of Ureteropelvic Junction Obstruction
Timepoint
before intervention 1 week later 3 and 6 months later to one year
Method of measurement
Ultra sonography ,radioisotope scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: asymptomatic patient under age of one year with ureteropelvic junction obstruction undergoing dismembered reduction pyeloplasty
Category
Treatment - Surgery
2
Description
Control group: asymptomatic patient under age of one year with ureteropelvic junction obstruction undergoing maintenance therapy.Follow up visits to the treatment center at specific intervals. At monthly urine test, ultrasound and isotope scans at intervals of 3 months 6 months to 1 year to check the progression of the disease.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children Hospital
Full name of responsible person
Khashayar Atqiaee
Street address
Mofid Children Hospital shariati Ave
City
Tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2222 7021
Email
khashayar_atqiaee@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khashayar Atqiaee
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9982
Email
khashayar_atqiaee@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khashayar Atqiaee
Position
pediatric surgery resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Mofid children Hospital,Shariati Ave
City
Tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2222 7021
Email
khashayar_atqiaee@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khashayar Atqiaee
Position
pediatric surgery resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Mofid children Hospital ,Shariati Ave
City
Tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2222 7021
Email
khashayar_atqiaee@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khashayar Atqiaee
Position
pediatric surgery resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Mofid children Hospital, Shariati Ave
City
Tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2222 7021
Email
khashayar_atqiaee@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the end of the study, the individual data of the participants in the study, which includes all the potential data after the unidentifiable individuals are shared
When the data will become available and for how long
The release date of this document/data file is 6 months after the publication of the results
To whom data/document is available
Our data will only be available to researchers working scientific and academic institutions
Under which criteria data/document could be used
Data usage is allowed if no change is made in the data and if the analysis of data needed, inform the author
From where data/document is obtainable
You can access the requested items by email to the author
What processes are involved for a request to access data/document
Information will be sent to you within 5 business days after the email is sent to the author
Comments
Contact the author by email if you need additional information